Relay device for transferring information between a sensor system and a fluid delivery system

ABSTRACT

A relay device transfers information between a sensor system, which measures a physiological characteristic level of a user, and a fluid delivery system, which infuses a fluid into a user. The relay device includes a sensor system receiver for receiving communications from the sensor system in a sensor system format. The relay device also includes a processor for processing the communications from the sensor system and converting the communications for transmission in a delivery system format. The relay device further includes a delivery system transmitter for transmitting the converted communications in the delivery system format to the fluid delivery system. The sensor system and delivery system formats may utilize different frequencies and/or different communication protocols for communications transmitted between the sensor system and the fluid delivery system through the relay device.

RELATED APPLICATIONS

[0001] This application claims priority on U.S. Provisional PatentApplication filed Dec. 19, 2002 and entitled “Relay Device forTransferring Information Between a Sensor System and a Fluid DeliverySystem,” which is herein specifically incorporated by reference.

BACKGROUND OF THE INVENTION

[0002] Ambulatory pumps and hospital-based fluid delivery systems areused to deliver fluids into the bodies of patients. For some therapies,sensor measurements of a patient's physiological characteristics areused to calculate fluid dosage requirements. Typically, a sensor monitoris used to collect sensor data from a sensor, calibrate the sensor datato generate sensor measurements, and display the sensor measurements.Next, the patient or a caregiver manually calculates the required fluiddosage based on the displayed sensor measurements. Finally, the patientor caregiver programs the pump or fluid delivery system to adjust thefluid dosage.

[0003] For example, patients with Type 1 diabetes and some patients withType 2 diabetes use insulin to control their blood glucose (BG) level.Typically, if a patient's BG level is too high, the patient can inject a“bolus” (dose) of insulin to lower his/her BG level from its presentlevel to a desired target level. Furthermore, the patient may inject abolus of insulin in anticipation of ingesting carbohydrates, thusheading off a sharp rise in his/her BG level. Presently, a patient orcaregiver must measure the patient's blood glucose using a BG monitoringsystem, such as a continuous glucose measurement system, a test stripmeter, a hospital-based measurement system, or an automated intermittentblood glucose measurement system. When the BG monitoring system hasgenerated a BG measurement, the BG measurement is displayed on the BGmonitoring system. Next, the patient or caregiver must visually read andthen utilize the BG measurement to manually calculate a required insulinbolus (i.e., the amount of insulin to inject). Finally, once therequired insulin bolus is calculated, the patient or caregiver mustutilize an insulin delivery device (e.g., infusion pump, injection pen,IV meter, or the like) to deliver the insulin bolus into the patient'sbody.

[0004] Unfortunately, this process requires the patient or caregiver tohandle several pieces of equipment, including the BG monitoring systemand the insulin delivery device, which may discourage the patient orcaregiver from using the BG measurements to adjust the insulin dosage,and thus, decrease the efficacy of the insulin delivery device.Additionally, if the BG monitoring system and the insulin deliverydevice are not developed in conjunction with one another, they typicallycommunicate using different frequencies and/or modes of communication,and as a result, cannot communicate directly with one another. Thus, thepatient or caregiver must manually calculate the required insulin bolusand program the insulin delivery device accordingly, which requireseffort by the patient or caregiver and is subject to calculation errors.Alternatively, the patient or caregiver must manually enter the BGmeasurement into an electronic computing device with bolus estimationsoftware for calculating the required insulin bolus (e.g., a computer,the Internet, a personal digital assistant (PDA), or an insulin deliverydevice, such as an infusion pump, injection pen, IV meter, or the like),which also requires effort by the patient or caregiver and is subject totranscription errors. For example, the patient or caregiver may notaccurately enter the BG measurement that is displayed on the BGmeasurement device into the electronic computing device, and thus, theresulting bolus estimate calculation may not be accurate.

SUMMARY OF THE INVENTION

[0005] It is an object of an embodiment of the present invention toprovide an improved infusion system including a relay device fortransferring information between a sensor system and a fluid deliverysystem, which obviates for practical purposes, the above mentionedlimitations.

[0006] According to an embodiment of the invention, an infusion systemfor infusing a fluid into a user includes a sensor system, a relaydevice, and a delivery system. The sensor system includes a sensorsystem housing, a sensor coupled to the sensor system housing forproducing a signal indicative of a physiological characteristic level ofthe user, a sensor system processor contained in the sensor systemhousing for processing the signal indicative of the physiologicalcharacteristic level of the user, and a sensor system transmittercontained in the sensor system housing and coupled to the sensor systemprocessor for transmitting one or more communications in a sensor systemformat. The relay device includes a relay device receiver for receivingthe communications from the sensor system in the sensor system format, arelay device processor for processing the communications from the sensorsystem and converting the communications for transmission in a deliverysystem format, and a relay device transmitter for transmitting theconverted communications in the delivery system format. The fluiddelivery system includes a delivery system housing, a delivery systemreceiver contained in the delivery system housing for receiving thecommunications from the relay device in the delivery system format, anda delivery system processor contained in the delivery system housing andcoupled to the delivery system receiver for processing thecommunications from the relay device in the delivery system format andcontrolling an amount of the fluid infused into the user. Further, theamount of the fluid infused into the user is determined based upon dataindicative of the physiological characteristic level of the user.

[0007] In particular embodiments, at least one of the communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system include data indicative of thephysiological characteristic level of the user. Additionally, thecommunications including the data indicative of the physiologicalcharacteristic level of the user may be automatically transmitted fromthe sensor system through the relay device and received by the fluiddelivery system. Further, the fluid delivery system may also include adisplay device contained in the delivery system housing and coupled tothe delivery system processor for automatically displaying to the userthe data indicative of the physiological characteristic level of theuser. Alternatively, the fluid delivery system may further include adisplay device contained in the delivery system housing and coupled tothe delivery system processor for displaying data to the user, and auser interface contained in the housing and coupled to the deliverysystem processor for accepting one or more inputs from the user. Atleast one of the inputs may cause the display device to display the dataindicative of the physiological characteristic level of the userreceived by the fluid delivery system. Also, the user interface may bededicated for interfacing with the data indicative of the physiologicalcharacteristic level of the user received by the fluid delivery system.

[0008] In other particular embodiments, the fluid delivery systemincludes a memory contained in the delivery system housing for storingthe data indicative of the physiological characteristic level of theuser received by the fluid delivery system. Also, the fluid deliverysystem may include a display device contained in the housing and coupledto the delivery system processor for displaying to the user a historicaltrend or graph using the stored data indicative of the physiologicalcharacteristic level of the user received by the fluid delivery system.

[0009] In still other particular embodiments, the fluid delivery systemmay include a display device contained in the delivery system housingand coupled to the delivery system processor for displaying data to theuser, and a user interface contained in the delivery system housing andcoupled to the delivery system processor for accepting one or moreinputs from the user. At least one of the inputs may cause the displaydevice to display the most recent data indicative of the physiologicalcharacteristic level of the user received by the fluid delivery system.Also, at least a portion of the user interface may be dedicated forinterfacing with the data indicative of the physiological characteristiclevel of the user received by the fluid delivery system.

[0010] In yet other particular embodiments, the fluid delivery systemincludes a display device contained in the delivery system housing andcoupled to the delivery system processor for displaying data to theuser, and a user interface contained in the delivery system housing andcoupled to the delivery system processor for accepting one or moreinputs from the user. At least one of the inputs causes the displaydevice to display the data indicative of the physiologicalcharacteristic level of the user received by the fluid delivery system.Further, at least a portion of the user interface may be dedicated forinterfacing with the data indicative of the physiological characteristiclevel of the user received by the fluid delivery system.

[0011] In still other embodiments, the fluid delivery system includes auser interface for accepting one or more inputs from the user, and theuser interface is contained in the delivery system housing and coupledto the delivery system processor. At least one of the inputs programsthe amount of the fluid infused into the user based upon the dataindicative of the physiological characteristic level of the userreceived by the fluid delivery system. In yet other embodiments, thefluid delivery system includes a bolus estimator used in conjunctionwith the delivery system processor for estimating the amount of thefluid to be infused into the user based upon the data indicative of thephysiological characteristic level of the user received by the fluiddelivery system, an indication device coupled to the bolus estimator forindicating the estimated amount of fluid to be infused into the user,and a user interface for accepting one or more inputs from the user. Atleast one of the inputs accepts or modifies the estimated amount of thefluid to be infused into the user. In additional embodiments, the fluiddelivery system includes a closed loop algorithm executed by thedelivery system processor for automatically determining the amount ofthe fluid to be infused into the user based upon the data indicative ofthe physiological characteristic level of the user received by the fluiddelivery system and causing the fluid delivery system to infuse thedetermined amount of the fluid into the user. In further embodiments,the fluid delivery system includes an indication device for indicatingwhen the data indicative of the physiological characteristic level ofthe user received by the fluid delivery system is above or below atarget characteristic value.

[0012] In still additional embodiments, the fluid delivery systemincludes a delivery system transmitter contained in the delivery systemhousing and coupled to the delivery system processor for transmittingone or more communications in the delivery system format. The relaydevice receiver further receives the communications from the fluiddelivery system in the delivery system format, the relay deviceprocessor processes the communications from the fluid delivery systemand converts the communications for transmission in the sensor systemformat, and the relay device transmitter transmits the convertedcommunications in the sensor system format. Also, the sensor systemfurther includes a sensor system receiver coupled to the sensor systemprocessor for receiving the communications from the relay device in thesensor system format.

[0013] In still further embodiments, the fluid delivery system includesa display device contained in the delivery system housing and coupled tothe delivery system processor for displaying data to the user, and auser interface contained in the delivery system housing and coupled tothe delivery system processor for accepting one or more inputs from theuser. At least one of the inputs generates a request for the dataindicative of the physiological characteristic level of the user fromthe sensor system, at least one of the communications transmitted fromthe fluid delivery system through the relay device to the sensor systemincludes the request, and at least one of the communications includingthe data indicative of the physiological characteristic level of theuser is transmitted from the sensor system through the relay device andreceived by the delivery system in response to the request. The displaydevice then displays the data indicative of the physiologicalcharacteristic level of the user received by the fluid delivery system.Additionally, the user interface may be dedicated for interfacing fromthe fluid delivery system with the sensor system through the relaydevice. Also, the requested data is the most recent data indicative ofthe physiological characteristic level of the user received by the fluiddelivery system.

[0014] In yet other embodiments, the data indicative of thephysiological characteristic level of the user received by the fluiddelivery system is uncalibrated data. The fluid delivery system includesa calibration algorithm executed by the delivery system processor forcalibrating the uncalibrated data to generate one or more measurementsindicative of the physiological characteristic level of the user.

[0015] In alternative embodiments, the data indicative of thephysiological characteristic level of the user received by the fluiddelivery system includes one or more calibrated measurements indicativeof the physiological characteristic level of the user. In particularalternative embodiments, the sensor system includes a calibrationalgorithm executed by the sensor system processor for calibrating thesignal indicative of the physiological characteristic level of the userto generate the one or more measurements indicative of the physiologicalcharacteristic level of the user, and the communications transmittedfrom the sensor system through the relay device and received by thefluid delivery system include the one or more measurements indicative ofthe physiological characteristic level of the user. In other particularalternative embodiments, the data indicative of the physiologicalcharacteristic level of the user received from the sensor system by therelay device is uncalibrated data. The relay device includes acalibration algorithm executed by the relay device processor forcalibrating the uncalibrated data to generate one or more measurementsindicative of the physiological characteristic level of the user, andthe communications transmitted from the relay device and received by thefluid delivery system include the one or more measurements indicative ofthe physiological characteristic level of the user.

[0016] In additional alternative embodiments, at least one of thecommunications transmitted from the sensor system through the relaydevice and received by the delivery system includes one or more commandsfor programming the amount of the fluid infused into the user based uponthe data indicative of the physiological characteristic level of theuser. In some embodiments, the sensor system includes a display devicecoupled to the sensor system processor for displaying data to the user,and a user interface coupled to the sensor system processor foraccepting one or more inputs from the user. At least one of the inputscauses the display device to display the data indicative of thephysiological characteristic level of the user obtained by the sensorsystem. Also, at least another one of the inputs generates the one ormore commands for programming the amount of the fluid infused into theuser based upon the data indicative of the physiological characteristiclevel of the user obtained by the sensor system. In other embodiments,the sensor system includes a closed loop algorithm executed by thesensor system processor for automatically generating the one or morecommands for programming the amount of the fluid to be infused into theuser based upon the data indicative of the physiological characteristiclevel of the user obtained by the sensor system.

[0017] In further alternative embodiments, at least one of thecommunications transmitted from the sensor system to the relay deviceincludes the data indicative of the physiological characteristic levelof the user, and at least one of the communications transmitted from therelay device and received by the fluid delivery system includes one ormore commands for programming the amount of the fluid infused into theuser based upon the data indicative of the physiological characteristiclevel of the user. In particular embodiments, the relay device includesa display device coupled to the relay device processor for displayingdata to the user, and a user interface coupled to the relay deviceprocessor for accepting one or more inputs from the user. At least oneof the inputs causes the display device to display the data indicativeof the physiological characteristic level of the user obtained by thesensor system. Also, at least another one of the inputs generates theone or more commands for programming the amount of the fluid infusedinto the user based upon the data indicative of the physiologicalcharacteristic level of the user obtained by the sensor system. In otherparticular embodiments, the relay device further includes a closed loopalgorithm executed by the relay device processor for automaticallygenerating the one or more commands for programming the amount of thefluid to be infused into the user based upon the data indicative of thephysiological characteristic level of the user obtained by the sensorsystem.

[0018] In yet additional embodiments, the sensor system format and thedelivery system format utilize different frequencies for communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system. In some embodiments, the sensor systemformat and the delivery system format utilize different communicationprotocols for communications transmitted from the sensor system throughthe relay device and received by the fluid delivery system. Thecommunication protocols may utilize different carrier media and/orinformation packaging for communications transmitted from the sensorsystem through the relay device and received by the fluid deliverysystem.

[0019] In particular embodiments, the delivery system processor has aunique identification code, and the sensor system processor has thecapability to learn the unique identification code of the deliverysystem processor. Further, the communications transmitted from thesensor system through the relay device and received by the fluiddelivery system include the unique identification code of the deliverysystem processor to substantially avoid interference with other devices.In other particular embodiments, the sensor system processor has aunique identification code, and the delivery system processor has thecapability to learn the unique identification code of the sensor systemprocessor. Further, the communications transmitted from the sensorsystem through the relay device and received by the fluid deliverysystem include the unique identification code of the sensor systemprocessor to substantially avoid interference with other devices. Instill other particular embodiments, the relay device processor has aunique identification code, and the sensor system processor has thecapability to learn the unique identification code of the relay deviceprocessor. Also, the communications transmitted from the sensor systemto the relay device include the unique identification code of the relaydevice processor to substantially avoid interference with other devices.In yet other particular embodiments, the relay device processor has aunique identification code, and the delivery system processor has thecapability to learn the unique identification code of the relay deviceprocessor. Also, the communications transmitted from the relay deviceand received by the fluid delivery system include the uniqueidentification code of the relay device processor to substantially avoidinterference with other devices.

[0020] In additional embodiments, the relay device is coupled to thedelivery system housing. In other embodiments, the relay device iscontained in the delivery system housing. In still other embodiments,the relay device is coupled to the sensor system housing. In furtherembodiments, the sensor system is a glucose monitoring system, and thefluid delivery system is an insulin infusion device.

[0021] In another embodiment of the present invention, a relay devicetransfers information between a sensor system and a fluid deliverysystem. The sensor system measures a physiological characteristic levelof a user, and the fluid delivery system infuses a fluid into the user.The relay device includes a sensor system receiver for receiving one ormore communications from the sensor system in a sensor system format, aprocessor for processing the communications from the sensor system andconverting the communications for transmission in a delivery systemformat, and a delivery system transmitter for transmitting the convertedcommunications in the delivery system format to the fluid deliverysystem.

[0022] In some embodiments, the relay device includes a delivery systemreceiver for receiving one or more communications from the fluiddelivery system in the delivery system format. The processor furtherprocesses the communications from the fluid delivery system and convertsthe communications for transmission in the sensor system format. Therelay device also includes a sensor system transmitter for transmittingthe converted communications in the sensor system format to the sensorsystem. In other embodiments, at least one of the communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system include data indicative of thephysiological characteristic level of the user. In yet otherembodiments, at least one of the communications transmitted from thesensor system through the relay device and received by the fluiddelivery system include one or more commands for programming an amountof the fluid to be infused into the user based upon data indicative ofthe physiological characteristic level of the user obtained by thesensor system.

[0023] In further embodiments, at least one of the communicationstransmitted from the sensor system to the relay device include dataindicative of the physiological characteristic level of the user, and atleast one of the communications transmitted from the relay device andreceived by the fluid delivery system include one or more commands forprogramming an amount of the fluid to be infused into the user basedupon the data indicative of the physiological characteristic level ofthe user. Additionally, the relay device may include a display devicecoupled to the processor for displaying data to the user, and a userinterface coupled to the processor for accepting one or more inputs fromthe user. At least one of the inputs causes the display device todisplay the data indicative of the physiological characteristic level ofthe user. Also, at least another one of the inputs generates the one ormore commands for programming the amount of the fluid to be infused intothe user based upon the data indicative of the physiologicalcharacteristic level of the user.

[0024] In still other embodiments, the sensor system format and thedelivery system format utilize different frequencies for communicationstransmitted from the sensor system through the relay device to the fluiddelivery system. In yet other embodiments, the sensor system format andthe delivery system format utilize different communication protocols forcommunications transmitted from the sensor system through the relaydevice to the fluid delivery system. The communication protocols mayutilize different carrier media and/or information packaging forcommunications transmitted from the sensor system through the relaydevice to the fluid delivery system.

[0025] In yet another embodiment of the present invention, a relaydevice transfers information between a sensor system and a fluiddelivery system. The sensor system measures a physiologicalcharacteristic level of a user, and the fluid delivery system infuses afluid into the user. The relay device includes a sensor systemtransceiver for transmitting and receiving one or more communications toand from the sensor system. The communications are transmitted andreceived in a sensor system format. The relay device also includes adelivery system transceiver for transmitting and receiving one or morecommunications to and from the fluid delivery system. The communicationsare transmitted and received in a delivery system format. The relaydevice further includes a processor for processing the communicationsfrom the sensor system and the fluid delivery system. The processorconverts the communications received from the sensor system in thesensor system format for transmission in the delivery system format tothe fluid delivery system, and further converts the communicationsreceived from the fluid delivery system in the delivery system formatfor transmission in the sensor system format to the sensor system.

[0026] In particular embodiments, at least one of the communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system include data indicative of thephysiological characteristic level of the user. In other particularembodiments, at least one of the communications transmitted from thesensor system through the relay device and received by the fluiddelivery system include one or more commands for programming an amountof the fluid to be infused into the user based upon data indicative ofthe physiological characteristic level of the user obtained by thesensor system.

[0027] In additional embodiments, at least one of the communicationstransmitted from the sensor system to the relay device include dataindicative of the physiological characteristic level of the user, and atleast one of the communications transmitted from the relay device andreceived by the fluid delivery system include one or more commands forprogramming an amount of the fluid to be infused into the user basedupon the data indicative of the physiological characteristic level ofthe user. Also, the relay device may include a display device coupled tothe processor for displaying data to the user, and a user interfacecoupled to the processor for accepting one or more inputs from the user.At least one of the inputs causes the display device to display the dataindicative of the physiological characteristic level of the user.Additionally, at least another one of the inputs generates the one ormore commands for programming the amount of the fluid to be infused intothe user based upon the data indicative of the physiologicalcharacteristic level of the user.

[0028] In further embodiments, the sensor system format and the deliverysystem format utilize different frequencies for communicationstransmitted between the sensor system and the fluid delivery systemthrough the relay device. In additional embodiments, the sensor systemformat and the delivery system format utilize different communicationprotocols for communications transmitted between the sensor system andthe fluid delivery system through the relay device. The communicationprotocols may utilize different carrier media and/or informationpackaging for communications transmitted between the sensor system andthe fluid delivery system through the relay device.

[0029] In still another embodiment of the present invention, an infusionsystem for infusing a fluid into a user includes a sensor system and afluid delivery system. The sensor system includes a sensor for producinga signal indicative of a physiological characteristic level of the user,a sensor system processor coupled to the sensor for processing thesignal indicative of the physiological characteristic level of the user,and a sensor system transmitter coupled to the sensor system processorfor transmitting one or more communications in a sensor system format.The fluid delivery system includes a delivery system housing, a relaydevice contained in the delivery system housing, a delivery systemreceiver, and a delivery system processor. The relay device includes arelay device receiver for receiving the communications from the sensorsystem in the sensor system format, a relay device processor forprocessing the communications from the sensor system and converting thecommunications for transmission in a delivery system format, and a relaydevice transmitter for transmitting the converted communications in thedelivery system format. The delivery system receiver is contained in thedelivery system housing and receives the communications from the relaydevice in the delivery system format. The delivery system processor isalso contained in the delivery system housing and is coupled to thedelivery system receiver, and processes the communications from therelay device in the delivery system format and controls an amount of thefluid infused into the user. The amount of the fluid infused into theuser is determined based upon data indicative of the physiologicalcharacteristic level of the user obtained by the sensor system.

[0030] In particular embodiments, at least one of the communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system include data indicative of thephysiological characteristic level of the user. Additionally, thecommunications including the data indicative of the physiologicalcharacteristic level of the user may be automatically transmitted fromthe sensor system through the relay device and received by the fluiddelivery system. Further, the fluid delivery system may also include adisplay device contained in the delivery system housing and coupled tothe delivery system processor for automatically displaying to the userthe data indicative of the physiological characteristic level of theuser.

[0031] In other particular embodiments, the fluid delivery systemincludes a display device contained in the delivery system housing andcoupled to the delivery system processor for displaying data to theuser, and a user interface contained in the delivery system housing andcoupled to the delivery system processor for accepting one or moreinputs from the user. At least one of the inputs causes the displaydevice to display the data indicative of the physiologicalcharacteristic level of the user received by the fluid delivery system.

[0032] In still other embodiments, the fluid delivery system includes amemory contained in the delivery system housing for storing the dataindicative of the physiological characteristic level of the userreceived by the fluid delivery system. Additionally, the fluid deliverysystem may include a display device contained in the delivery systemhousing and coupled to the delivery system processor for displaying tothe user a historical trend or graph using the stored data indicative ofthe physiological characteristic level of the user received by the fluiddelivery system. Alternatively, the fluid delivery system may include adisplay device contained in the delivery system housing and coupled tothe delivery system processor for displaying data to the user, and auser interface contained in the delivery system housing and coupled tothe delivery system processor for accepting one or more inputs from theuser. At least one of the inputs causes the display device to displaythe most recent data indicative of the physiological characteristiclevel of the user received by the fluid delivery system.

[0033] In additional embodiments, the fluid delivery system includes adisplay device contained in the delivery system housing and coupled tothe delivery system processor for displaying data to the user, and auser interface contained in the delivery system housing and coupled tothe delivery system processor for accepting one or more inputs from theuser. At least one of the inputs causes the display device to displaythe data indicative of the physiological characteristic level of theuser received by the fluid delivery system. In further embodiments, thefluid delivery system includes a user interface contained in thedelivery system housing and coupled to the delivery system processor foraccepting one or more inputs from the user. At least one of the inputsprograms the amount of the fluid infused into the user based upon thedata indicative of the physiological characteristic level of the userreceived by the fluid delivery system.

[0034] In yet other embodiments, the fluid delivery system includes abolus estimator used in conjunction with the delivery system processorfor estimating the amount of the fluid to be infused into the user basedupon the data indicative of the physiological characteristic level ofthe user received by the fluid delivery system, an indication devicecoupled to the bolus estimator for indicating the estimated amount offluid to be infused into the user, and a user interface for acceptingone or more inputs from the user. At least one of the inputs accepts ormodifies the estimated amount of the fluid to be infused into the user.In still further embodiments, the fluid delivery system includes aclosed loop algorithm executed by the delivery system processor forautomatically determining the amount of the fluid to be infused into theuser based upon the data indicative of the physiological characteristiclevel of the user received by the fluid delivery system and causing thefluid delivery system to infuse the determined amount of the fluid intothe user. In still additional embodiments, the fluid delivery systemincludes an indication device for indicating when the data indicative ofthe physiological characteristic level of the user received by the fluiddelivery system is above or below a target characteristic value. In evenadditional embodiments, the data indicative of the physiologicalcharacteristic level of the user received by the fluid delivery systemis uncalibrated data, and the fluid delivery system further includes acalibration algorithm executed by the delivery system processor forcalibrating the uncalibrated data to generate one or more measurementsindicative of the physiological characteristic level of the user.

[0035] In some embodiments, the sensor system format and the deliverysystem format utilize different frequencies for communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system. In other embodiments, the sensor systemformat and the delivery system format utilize different communicationprotocols for communications transmitted from the sensor system throughthe relay device and received by the fluid delivery system. Thedifferent communication protocols may utilize different carrier mediaand/or information packaging for communications transmitted from thesensor system through the relay device and received by the fluiddelivery system.

[0036] In yet further embodiments, the delivery system processor has aunique identification code, and the sensor system processor has thecapability to learn the unique identification code of the deliverysystem processor. The communications transmitted from the sensor systemthrough the relay device and received by the fluid delivery systeminclude the unique identification code of the delivery system processorto substantially avoid interference with other devices. In yetadditional embodiments, the sensor system processor has a uniqueidentification code, and the delivery system processor has thecapability to learn the unique identification code of the sensor systemprocessor. The communications transmitted from the sensor system throughthe relay device and received by the fluid delivery system include theunique identification code of the sensor system processor tosubstantially avoid interference with other devices. Other features andadvantages of the invention will become apparent from the followingdetailed description, taken in conjunction with the accompanyingdrawings which illustrate, by way of example, various features ofembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0037] A detailed description of embodiments of the invention will bemade with reference to the accompanying drawings, wherein like numeralsdesignate corresponding parts in the several figures.

[0038]FIG. 1 is a block diagram of a system for transferring informationbetween a blood glucose monitoring system and an infusion pump through arelay device in accordance with an embodiment of the present invention.

[0039]FIG. 2(a)-2(c) are perspective views of a blood glucose monitoringsystem in accordance with embodiments of the present invention.

[0040]FIG. 3(a) is a perspective view of an external infusion pump inaccordance with an embodiment of the present invention.

[0041]FIG. 3(b) is a simplified block diagram of an external infusionpump in accordance with an embodiment of the present invention.

[0042] FIGS. 4(a)-5(f) are block diagrams of a system for transferringinformation between a blood glucose monitoring system and an infusionpump through a relay device in accordance with embodiments of thepresent invention.

[0043] FIGS. 6(a)-6(d) are perspective views of a relay device inaccordance with embodiments of the present invention.

[0044] FIGS. 7(a)-7(c) are perspective views of a relay device placed ona body of a user in accordance with embodiments of the presentinvention.

[0045] FIGS. 8(a)-8(c) are perspective views of a relay device placed onan infusion pump in accordance with embodiments of the presentinvention.

[0046]FIG. 8(d) is a cut-away perspective view of an infusion pump witha relay device included in the infusion pump in accordance with anotherembodiment of the present invention.

[0047] FIGS. 9(a)-9(e) are block diagrams of a relay device inaccordance with embodiments of the present invention.

[0048]FIG. 10 is a block diagram of a system for transferringinformation between a blood glucose monitoring system and an infusionpump using a relay device incorporated into the infusion pump inaccordance with another embodiment of the present invention.

[0049]FIG. 11 is a block diagram of a system for transferringinformation between a blood glucose monitoring system and an infusionpump using a relay device incorporated into the infusion pump inaccordance with yet another embodiment of the present invention.

[0050]FIG. 12 is a block diagram of a system for transferringinformation between a blood glucose monitoring system and an infusionpump using a relay device incorporated into the infusion pump inaccordance with still another embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0051] As shown in the drawings for purposes of illustration, theinvention is embodied in a relay device for transferring informationbetween a sensor system for measuring a physiological characteristiclevel of a user's body and a fluid delivery system for delivering fluidinto the user's body. The relay device receives information from onesystem in a first format, converts the information into a second formatappropriate for the other system, and then transmits the convertedinformation to the other system. Therefore, the relay device enablescommunication between the sensor system and the fluid delivery system,even if the systems are not developed in conjunction with one another.For example, sensor data or measurements may be communicated from thesensor system via the relay device to the fluid delivery system, andthen utilized to adjust the amount of fluid delivered by the fluiddelivery system into the user's body. Thus, the relay device encouragesthe user or caregiver to utilize the sensor data or measurements inorder to adjust the amount of fluid delivered into the user's body bythe fluid delivery system. Further, the sensor measurements may bedisplayed on the fluid delivery system for the user or caregiver to see.Therefore, the relay device allows the user or caregiver to interfacewith the sensor system (e.g., view the sensor measurements) utilizing asingle device, the fluid delivery system. Particular embodiments aredirected toward use of ambulatory sensor and fluid delivery systems thatare programmed and adjusted primarily by the user or a caregiver, suchas the user's parent. Other embodiments are directed toward use ofhospital-based sensor and fluid delivery systems that are programmed andadjusted primarily by a caregiver, such as the user's physician ornurse.

[0052] In preferred embodiments, the sensor system is a blood glucose(BG) monitoring system, which utilizes a sensor placed in a user toautomatically measure the user's BG level, either periodically orcontinuously. In particular embodiments, the sensor may measureadditional physiological characteristic levels of the user, such asblood oxygen, temperature, and the like. The sensor may be implanted inand/or through subcutaneous, dermal, sub-dermal, inter-peritoneal, orperitoneal tissue, and may be a sensor in contact with the user's bodyfluid, such as the user's blood, interstitial fluid, and the like. Inpreferred embodiments, the fluid delivery system is an insulin deliverydevice, such as an external insulin infusion pump, which regulates theamount of insulin delivered into the user's body. The relay devicereceives information from one system in a first format, converts theinformation into a second format appropriate for the other system, andthen transmits the converted information to the other system. Forexample, the relay device may receive BG data or measurements from theBG monitoring system in a sensor system format (e.g., at a frequency of131 kilohertz, utilizing radio frequency (RF) carrier media, in packetsof 107 bytes), convert such data or measurements into a delivery systemformat appropriate for the insulin infusion pump (e.g., to a frequencyof 916 megahertz, utilizing infrared (IR) carrier media, in packets of71 bytes), and then transmit such converted data or measurements to theinsulin infusion pump. The amount of insulin delivered into the user'sbody by the infusion pump may then be adjusted, either manually by theuser or a caregiver or automatically, in response to the received BGdata or measurements. In some embodiments, the BG measurements may alsobe displayed on the insulin infusion pump.

[0053] However, in alternative embodiments of the present invention, thesensor system may include other types of sensors, such as optical,enzymatic, fluorescent, or the like. In additional alternativeembodiments, the sensor system may measure the user's BG level only whenrequested by the user, or a BG meter may be utilized to measure theuser's BG level based on a sampling of the user's blood. In furtheralternative embodiments, the sensor system may measure otherphysiological characteristic levels of the user, such as heart rate,blood oxygen, pH, peroxide, respiratory rate, body temperature, bloodpressure, perspiration, brain wave activity, cholesterol level, ketonelevel, medication concentration, viral load (e.g., HIV), and the like.The sensor system may also include multiple sensors—one or more sensorsto measure the user's BG level and one or more sensors to measure suchother physiological characteristic levels of the user. In otheralternative embodiments, the sensor system may measure the physiologicalcharacteristic levels of the user from body fluids other than blood,such as interstitial fluid, spinal fluid, saliva, urine, tears, sweat,or the like. In still other alternative embodiments, the fluid deliverysystem may be an implantable infusion pump, an infusion pump that uses acombination of implantable and external components, a pen injector, adisposable pump, an intra venous drip system, or the like. In yet otheralternative embodiments, the fluid delivery system may deliver fluidsother than insulin, including peptides, proteins, sugars, vitamins,antigens, hormones, steroids, medicaments, drugs, pain killers,anti-cancer agents, anti-coagulants, stimulants, tranquilizers,sedatives, and the like. Particular embodiments are directed towards usein humans; however, alternative embodiments may be used in animals.

[0054] In preferred embodiments of the present invention, a relay devicetransfers information between a sensor system for measuring aphysiological characteristic level of a user's body and a fluid deliverysystem for delivering fluid into the user's body. In the embodimentillustrated in FIG. 1, the sensor system is a BG monitoring system 20,which utilizes a sensor that is placed in a user to measure the user'sBG level. The sensor may measure additional physiological characteristiclevels of the user, such as blood oxygen, temperature, or the like.

[0055] In particular embodiments, the BG monitoring system 20 is animplantable glucose monitoring system, and is generally of the typedescribed in U.S. Pat. No. 6,368,274, and disclosed in U.S. patentapplication Ser. No. 10/034,740, filed Dec. 27, 2001 and entitled“Implantable Sensor Flush Sleeve,” and U.S. Provisional PatentApplication filed Sep. 27, 2002 and entitled “Implantable Sensor Methodand System,” which are herein incorporated by reference. Referring toFIG. 2(a), the BG monitoring system 20 includes a glucose sensor set 50and a glucose monitor 54. The sensor set 50 and glucose monitor 54 areimplanted in the user's sub-dermal or inter-peritoneal tissue, and arein contact with the user's blood or other body fluid, to measure theuser's BG level. For example, the sensor set 50 may be implanted intothe central vein of the user's heart, and the glucose monitor 54 may belocated in the user's chest cavity. Alternatively, the sensor set 50 maybe placed in the user's peritoneum, and the glucose monitor 54 may belocated in the user's abdominal cavity. The glucose monitor 54 includesa processor (not shown) for processing data as it is received from thesensor set 50, and a transmitter and/or receiver (not shown) fortransferring the data to and/or from a data processor, such as adedicated processor 56 designed specifically to work with the glucosemonitor 54, a computer, communication station, or the like. The dataprocessor 56 preferably comprises a relatively compact, portable housingthat may be easily worn on clothing or jewelry, placed in a pocket,concealed under clothing, or the like. However, the BG monitoring system20 may also be included in a hospital-based system, and the dataprocessor 56 may comprise a housing that may be included in a monitor,placed on an intravenous (IV) pole, or the like near the patient's bed.

[0056] In other particular embodiments, the BG monitoring system 20 is atelemetered glucose monitoring system, and may generally be of the typedescribed in U.S. patent application Ser. No. 09/377,472, filed Aug. 19,1999 and entitled “Telemetered Characteristic Monitor System and Methodof Using the Same,” which is herein incorporated by reference. The BGmonitoring system 20 may also be a vascular glucose monitoring system,and may generally be of the type described in U.S. patent applicationSer. No. 10/036,93, filed Dec. 28, 2001 and entitled “Sensing Apparatusand Process,” and U.S. Provisional Patent Application filed Sep. 27,2002 and entitled “Multilumen Catheter,” which are herein incorporatedby reference. Referring to FIG. 2(b), the BG monitoring system 20′ mayinclude a glucose sensor set 50′ and a glucose monitor 54′. The sensorset 50′ includes a glucose sensor that is placed in and/or through theuser's subcutaneous, dermal, sub-dermal, inter-peritoneal, peritoneal,muscle, lymph, or organ tissue, veins, arteries, or the like, and may bein contact with the user's blood or other body fluid, to measure theuser's BG level. The sensor set 50′ is connected to the glucose monitor54′ via a cable 52, and the glucose monitor 54′ includes a processor(not shown) for processing data as it is received from the sensor set50′ via the cable 52. For example, the sensor set 50′ may be placed inthe user's subcutaneous tissue, and the glucose monitor 54′ may beadhered to the user's body. Alternatively, the sensor set 50′ may beinserted into one lumen of a multilumen catheter, which may then beimplanted in the central vein of the user's heart and include anextension lead for connecting to the glucose monitor 54′ via the cable52, and the glucose monitor 54′ may be adhered to the user's body, asshown in FIG. 11. The other lumen(s) of the multilumen catheter may beutilized for sampling other physiological characteristic levels of theuser and/or delivering fluids into the user's body, such as proteinnutrition, blood products, medication, lipids, and the like. Such amultilumen catheter may generally be of the type described in U.S.Provisional Patent Application filed Sep. 27, 2002 and entitled“Multilumen Catheter,” which is herein incorporated by reference.

[0057] The glucose monitor 54′ may also include a transmitter and/orreceiver (not shown) for transferring the data to and/or from a dataprocessor, such as a dedicated processor 56′ designed specifically towork with the glucose monitor 54′ , a computer, communication station,or the like. The data processor 56′ preferably comprises a relativelycompact, portable housing that may be easily worn on clothing orjewelry, placed in a pocket, concealed under clothing, or the like.However, the BG monitoring system 20 may also be included in ahospital-based system, and the data processor 56′ may comprise a housingthat may be included in a monitor, placed on an intravenous (IV) pole,or the like near the patient's bed. In alternative embodiments, thecable 52 may be omitted, and the sensor set 50′ may be directlyconnected to the glucose monitor 54′.

[0058] In yet other particular embodiments, the BG monitoring system 20may be a continuous glucose monitoring system, and may generally be ofthe type described in U.S. Pat. No. 6,424,847, which is hereinincorporated by reference. Referring to FIG. 2(c), the BG monitoringsystem 20″ may include a glucose sensor set 50″ and a glucose monitor5″. The sensor set 50″ includes a glucose sensor that is placed inand/or through the user's subcutaneous, dermal, sub-dermal,inter-peritoneal, peritoneal, muscle, lymph, or organ tissue, veins,arteries, or the like, and may be in contact with the user's blood orother body fluid, to measure the user's BG level. The sensor set 50″ isconnected to the glucose monitor 54″ via a cable 52′, and the glucosemonitor 54″ includes a processor (not shown) for processing data as itis received from the sensor set 50″ via the cable 52′. The glucosemonitor 54″ comprises a relatively compact, portable housing that may beeasily worn on clothing or jewelry, placed in a pocket, concealed underclothing, or the like. However, the BG monitoring system 20 may also beincluded in a hospital-based system, and the glucose monitor 54″ maycomprise a housing that may be included in a monitor, placed on anintravenous (IV) pole, or the like near the patient's bed. The glucosemonitor 54″ may also include a transmitter and/or receiver (not shown)for transferring the data to and/or from a data processor (not shown),such as a computer, communication station, or the like. In alternativeembodiments, the cable 52′ may be omitted, and the sensor set 50″ may bedirectly connected to the glucose monitor 54″.

[0059] In alternative embodiments, the BG monitoring system 20 mayinclude other types of sensors, such as optical, enzymatic, fluorescent,or the like. In further alternative embodiments, the sensor system maymeasure other physiological characteristic levels of the user, such asheart rate, blood oxygen, pH, peroxide, respiratory rate, bodytemperature, blood pressure, perspiration, brain wave activity,cholesterol level, ketone level, medication concentration, viral load(e.g., HIV), and the like. The sensor system may also include multiplesensors—one or more sensors to measure the user's BG level and one ormore sensors to measure such other physiological characteristic levelsof the user. For example, the BG monitoring system 20 may include aglucose sensor set 50 inserted in or on the user's body to measure theuser's BG level and an oxygen sensor to measure the oxygen level at ornear the insertion site of the sensor set 50. The measured oxygen levelmay then be used to determine the effectiveness of the sensor set 50,the formation of foreign bodies near the sensor set 50, or the like. Inother alternative embodiments, the sensor system may measure thephysiological characteristic levels of the user from body fluids otherthan blood, such as interstitial fluid, spinal fluid, saliva, urine,tears, sweat, or the like.

[0060] In particular embodiments, the BG monitoring system 20automatically measures the user's BG level on a periodic basis. In otherparticular embodiments, the BG monitoring system 20 automaticallymeasures the user's BG level on a continuous basis. In alternativeembodiments, the BG monitoring system 20 may not automatically measurethe user's BG level. For example, the BG monitoring system 20 mayinclude a user interface, such as a keypad 60, which may be utilized bythe user to request a BG measurement from the BG monitoring system 20.Alternatively, the BG monitoring system 20 may include a BG meter, whichmeasures the user's BG level based on a sampling of the user's blood.

[0061] In preferred embodiments, the BG monitoring system 20 includes atransmitter and/or receiver (not shown) for communicating with externaldevices, such as a remote programmer (not shown) for the BG monitoringsystem 20, a BG meter (not shown), the relay device 10, the infusionpump 30 via the relay device 10, or the like. For example, the glucosemonitor 54 and/or data processor 56 may include the transmitter and/orreceiver. The BG monitoring system 20 preferably communicates with suchexternal devices using radio frequency (RF) communication.Alternatively, other modes of communication may be utilized, such asinfrared (IR), wired, ultrasonic, optical, or the like.

[0062] In particular embodiments, the BG monitoring system 20 may alsoinclude a display and a user interface. Referring to FIGS. 2(a)-2(b),the data processor 56 includes a display 58 and a keypad 60 with one ormore keys. The glucose monitor 54 utilizes the transmitter and/orreceiver (not shown) to transfer data to and/or from the data processor56. Alternatively, referring to FIG. 2(c), the glucose monitor 54″ mayinclude the display 58″ and keypad 60″ with one or more keys. The usermay utilize the display 58 and/or keypad 60 to display the user'scurrent BG level, view other BG information recorded or calculated bythe glucose monitor 54 and/or data processor 56 (e.g., average BG level,BG trends, graphs of historical BG measurements), view alarms or othermessages, program the BG monitoring system 20, enter calibration orother data into the BG monitoring system 20, download information fromthe BG monitoring system 20, and the like. In particular embodiments,the user may also utilize the display 58 and/or keypad 60 to transmitdata, delivery commands, and/or other information to the infusion pump30 via the relay device 10. In alternative embodiments, the userinterface may include one or more buttons, switches, levers, joystick,roller ball, mouse, keyboard, and the like. In further alternativeembodiments, the keypad 60 may be omitted, and the display 58 may beused as a touch screen input device. In other alternative embodiments,the display and/or user interface may be omitted from the BG monitoringsystem 20, and instead included on the relay device 10 and/or infusionpump 30.

[0063] In preferred embodiments, the BG monitoring system 20 storesinformation in a memory (not shown) of the BG monitoring system 20 forsubsequent review and/or downloading to a storage media. Informationstored by the BG monitoring system 20 may include one or more of raw BGdata, calibrated BG measurements, time stamps, sensor alarms, sensorsettings, calibration data, sensor performance data, sensor errors,sensor system diagnostics, statistics, user information, serial number,and the like. In preferred embodiments, information is transmitted fromthe BG monitoring system 20 to the infusion pump 30 via the relay device10, and then downloaded to a storage media from the infusion pump 30.The storage media may include one or more of a personal computer (PC), acentral server, an electronic memory, a personal digital assistant(PDA), a cell phone, a laptop computer, magnetic memory, silicon memory,a data storage device, and the like. In alternative embodiments,information may be downloaded to the storage media directly from the BGmonitoring system 20 through an interface, such as a transmitter, acable, a communication station, or the like. In particular alternativeembodiments, information may be downloaded from the data processor 56 tothe storage media. In other alternative embodiments, information may bedownloaded from the glucose monitor 54 to the storage media. In furtheralternative embodiments, information may be transmitted from the BGmonitoring system 20 to the relay device 10, and then downloaded to thestorage media from the relay device 10. In other alternativeembodiments, information may be downloaded to the storage media frommore than one of the BG monitoring system 20, relay device 10, andinfusion pump 30.

[0064] In preferred embodiments, sensor calibration data is provided tothe BG monitoring system 20 by communication with an external device,such as a BG meter or other BG measuring device (not shown). The BGmonitoring system 20 preferably includes a transmitter and/or receiver(not shown) for communicating with such external devices. For example,the glucose monitor 54 and/or the data processor 56 may include thetransmitter and/or receiver. The user obtains a BG reference readingutilizing a BG meter or other BG measuring device, which then transmitsthe BG reference reading to the BG monitoring system 20, either directlyor via the relay device 10. In alternative embodiments, the user maymanually enter sensor calibration data into the BG monitoring system 20.In particular alternative embodiments, the user may utilize the display58 and/or user interface 60 on the data processor 56, as shown in FIGS.2(a)-2(b), to manually input the calibration data into the BG monitoringsystem 20. In other particular alternative embodiments, the user mayutilize the display 58″ and/or user interface 60″ on the glucose monitor54″ , as shown in FIG. 2(c), to manually input the calibration data intothe BG monitoring system 20.

[0065] In the embodiment illustrated in FIGS. 1 and 3(a)-3(b), the fluiddelivery system is an external infusion pump 30, which regulates theflow of fluid, preferably medication such as insulin, through flexibletubing 32 and into an infusion set 34 or the like that is adhered to theuser's body. Infusion sets 34 that may be used are described in, but notlimited to, U.S. Pat. Nos. 4,723,947; 4,755,173; 5,176,662; 5,584,813;and 6,056,718, which are herein incorporated by reference. The infusionpump 30 is generally of the type described in U.S. Pat. Nos. 4,562,751;4,685,903; 5,080,653; 5,097,122; 5,505,709; and 6,248,093; and disclosedin U.S. patent application Ser. No. 09/334,858, filed Jun. 16, 1999 andentitled “External Infusion Device with Remote Programming, BolusEstimator and/or Vibration Alarm Capabilities,” which are hereinincorporated by reference. In alternative embodiments, the fluiddelivery system may be an implantable infusion pump, an infusion pumpthat uses a combination of implantable and external components, a peninjector, disposable pump, an intra venous drip system, or the like. Instill other alternative embodiments, the fluid delivery system maydeliver fluids other than insulin, including peptides, proteins, sugars,vitamins, antigens, hormones, steroids, medicaments, drugs, painkillers, anti-cancer agents, anti-coagulants, stimulants, tranquilizers,sedatives, and the like.

[0066] Referring to FIGS. 3(a)-3(b), the infusion pump 30 comprises arelatively compact, portable housing that may be easily worn on clothingor jewelry, placed in a pocket, concealed under clothing, or the like.However, the infusion pump 30 may also be included in a hospital-basedsystem, and the infusion pump 30 may comprise a housing that may beincluded in a monitor, placed on an intravenous (IV) pole, or the likenear the patient's bed. The infusion pump 30 preferably includes aprocessor 150 for running programs and controlling the infusion pump 30.The processor 150 is coupled to an internal memory device 154 thatstores programs, history data, user defined information and parameters.In preferred embodiments, the memory device 154 is a ROM and DRAM;however, in alternative embodiments, the memory device 154 may includeother memory storage devices, such as RAM, EPROM, dynamic storage suchas flash memory, energy efficient hard-drive, or the like. The processor150 is also coupled to a drive mechanism 160 that is connected to afluid reservoir 162 containing fluid that is delivered through thetubing 32 and into the infusion set 34 adhered to the user's body. Theprocessor 150 may additionally be coupled to a bolus estimator 164,which estimates an appropriate amount of insulin to be delivered to theuser based on the user's BG level, the amount of carbohydrates to beconsumed, and the like. The bolus estimator 164 may generally be of thetype described in U.S. patent application Ser. No. 09/334,858, filedJun. 16, 1999 and entitled “External Infusion Device with RemoteProgramming, Bolus Estimator and/or Vibration Alarm Capabilities,” whichis herein incorporated by reference.

[0067] The infusion pump 30 further includes a communication system 152coupled to the processor 150 for communicating with external devices,such as a remote programmer (not shown) for the infusion pump 30, the BGmonitoring system 20 via the relay device 10, the relay device 10, orthe like. The communication system 152 may include a transmitter and/orreceiver (not shown) for communicating with such external devices. Theinfusion pump 30 preferably communicates with such external devicesusing radio frequency (RF) communication. Alternatively, other modes ofcommunication may be utilized, such as infrared (IR), wired, ultrasonic,optical, or the like.

[0068] In some embodiments, the transmitter and/or receiver (not shown)of the communication system 152 may be capable of communicating withcertain external devices utilizing a particular frequency and/orcommunication protocol, such as the remote programmer (not shown) forthe infusion pump 30 or the like. The infusion pump 30 may includeanother transmitter and/or receiver (not shown) as part of the relaydevice 10 incorporated in the infusion pump 30 itself (as shown anddescribed below in the embodiment of FIGS. 8(d) and 10-12), which iscapable of communicating with other external devices utilizing anotherparticular frequency and/or communication protocol, such as the BGmonitoring system 20 or the like. In other embodiments, the transmitterand/or receiver (not shown) of the communication system 152 may becapable of communicating with various external devices utilizingdifferent frequencies and/or communication protocols.

[0069] The infusion pump 30 also includes a display 100 and/or a userinterface 110. In preferred embodiments, the display 100 is amonochromatic liquid crystal display (LCD). In alternative embodiments,the display 100 is a light emitting diode (LED) display, a cathode raytube (CRT) display, a touch screen, a color LCD, or the like.

[0070] In preferred embodiments, the user interface is a keypad 110including one or more keys with selectable functions. The infusion pump30 is preferably programmed through the keypad 110, or alternatively, bycommands received from an external device, such as a remote programmer,the BG monitoring system 20 via the relay device 10, the relay device10, or the like. The keypad 110 may generally be of the type, andoperate in a manner similar to that, disclosed in U.S. patentapplications Ser. No. 09/334,858, filed Jun. 16, 1999 and entitled“External Infusion Device with Remote Programming, Bolus Estimatorand/or Vibration Alarm Capabilities,” and Ser. No. 09/784,949, filedFeb. 15, 2001 and entitled “Improved Infusion Device Menu Structure andMethod of Using the Same,” which are herein incorporated by reference.

[0071] In the illustrated embodiment, the keypad 110 includes anUp-Arrow key 112, a Down-Arrow key 114, an ACT (activate) key 116, anESC (escape) key 118, and an Express Bolus key 120 for programming theinfusion pump 30. The keypad 110 also includes a dedicated key 122 forinterfacing with the BG monitoring system 20 via the relay device 10. Inparticular embodiments, the user chooses a function and then selectswhich key will perform that function. For example, while the display 100is blank, the user may select the Express Bolus key 120 to quickly set abolus amount, or the ESC key 118 to show a status information screen onthe display 100. In other particular embodiments, the user selects oneor more keystrokes to perform a function. For example, while the display100 is blank, the user may first select the ACT key 116 to show a mainmenu screen, then the Up-Arrow and Down-Arrow keys 112 and 114 to scrollthrough the menu choices, and then the ACT key 116 again to select amenu option. The user selects the keys 112, 114, 116, 118, 120, and/or122 on the keypad 110 to perform functions on the infusion pump 30, suchas starting or stopping a bolus or basal delivery, accessing historicaldata or status information, setting a utility (e.g., date, time, serialnumber, or the like), turning on or off a feature (e.g., light, keylock, temporary operation, or the like), escaping to a home displayscreen, backing up to a previous screen, deleting or approving an input,scrolling, priming, resetting, and the like. In particular embodiments,the display 100 and/or user interface 110 may also be utilized to inputinformation into and/or display information from the BG monitoringsystem 20 via the relay device 10, such as viewing sensor measurementsreceived from the BG monitoring system 20 on the display 100 of theinfusion pump 30. In alternative embodiments, the keypad 110 may includemore or less keys, or have different key arrangements than thoseillustrated in the figures.

[0072] In further alternative embodiments, one or more keys on thekeypad 110 may be programmable. In particular embodiments, the user maydefine one or more keystrokes to cause the infusion pump 30 to performone or more functions. For example, a first user may define key 120 on afirst infusion pump 30 to cause the display 100 to show the most recentsensor measurement, while a second user may define key 120 on a secondinfusion pump 30 to perform an express bolus function. In otheralternative embodiments, the user interface may include one or morebuttons, switches, levers, joysticks, roller balls, mice, keyboards, andthe like. In still other alternative embodiments, the keypad 110 may beomitted, and the display 100 may be used as a touch screen input device.

[0073] The infusion pump 30 may provide feedback to the user on statusor programming changes visibly on the display 100 and/or through lights(not shown) on the infusion pump 30, audibly through a speaker 156,and/or tactilely through a vibrator 158. The infusion pump 30 may alsoprovide the user with a visible alarm via the display 100 and/or lights,an audible alarm via the speaker 156, and/or a vibration alarm via thevibrator 158, such as a warning that is indicative of a low reservoir orlow battery, an alarm or warning that is indicative of a sensormeasurement received from the BG monitoring system 20 via the relaydevice 10 that is above or below target glycemic values, or the like. Inalternative embodiments, the display 100, keypad 110, lights, speaker156, and/or vibrator 158 may be omitted from the infusion pump 30, andinstead, included on the relay device 10 and/or the BG monitoring system20. In further alternative embodiments, the display 100, keypad 110,lights, speaker 156, and/or vibrator 158 may be omitted, the infusionpump 30 may be implanted in the user's body, and all programming may behandled through a communication system using wireless modes ofcommunication, such as radio frequency (RF), infrared (IR), and thelike.

[0074] In preferred embodiments, the infusion pump 30 stores informationin a memory (not shown) of the infusion pump 30 for subsequent reviewand/or downloading to a storage media. Information stored by theinfusion pump 30 includes one or more of insulin delivery rates, insulinbolus amounts, time stamps, alarms, errors, warnings, utility settings,statistics, profiles, user information, serial number, commands, forcemeasurements, pressure measurements, and the like. In preferredembodiments, information is downloaded directly from the infusion pump30 to a storage media through an interface, such as a transmitter,cable, communication station, or the like. In particular embodiments, anexternal communication link (not shown) may be connected via a cable toa serial, USB, or the like port of a computer. The infusion pump 30 mayinclude an RF transmitter or transceiver (not shown), which transmitsinformation to an RF receiver or transceiver in the externalcommunication link for downloading to the computer. In other particularembodiments, information may be downloaded from the infusion pump 30through a communication station generally of the type disclosed in U.S.Pat. No. 5,376,070, which is herein incorporated by reference. In stillother particular embodiments, information may be downloaded from theinfusion pump 30 through a BG meter (not shown) as disclosed in U.S.Provisional Patent Application Serial No. 60/412,998, filed Sep. 23,2002 and entitled “System for Providing Blood Glucose Measurements toBolus Estimator,” which is herein incorporated by reference. The storagemedia may include one or more of a personal computer (PC), a centralserver, an electronic memory, a personal digital assistant (PDA), a cellphone, a laptop computer, magnetic memory, silicon memory, a datastorage device, and the like. In alternative embodiments, informationmay be transmitted from the infusion pump 30 to the BG monitoring system20 via the relay device 10, and then downloaded to a storage media fromthe BG monitoring system 20. In further alternative embodiments,information may be transmitted from the infusion pump 30 to the relaydevice 10, and then downloaded to the storage media from the relaydevice 10. In other alternative embodiments, information may bedownloaded to the storage media from more than one of the BG monitoringsystem 20, relay device 10, and infusion pump 30.

[0075] In the embodiment illustrated in FIG. 1, the relay device 10transfers information between the BG monitoring system 20 and theinfusion pump 30. In preferred embodiments, the relay device 10comprises a relatively compact, portable housing 200 without a userinterface or a display, as illustrated in FIG. 6(a). The relay device 10may be easily worn on clothing or jewelry, placed in a pocket, concealedunder clothing, or the like. In alternative embodiments, the relaydevice 10′ may include a housing 200′ with a single key 202, as shown inFIG. 6(b). The single key 202 provides a user interface for the user torequest new information from the BG monitoring system 20.

[0076] In further alternative embodiments, the relay device 10″ mayinclude a housing 200″ with a keypad 204, as shown in FIG. 6(c). Thekeypad 204 may include more than one key, and at least one of the keysmay be utilized by the user to send data or commands to the infusionpump 30. In the illustrated embodiment, the keypad 204 includes anUp-Arrow key 206, a Down-Arrow key 208, and an ACT (activate) key 210for programming the infusion pump 30 from the relay device 10 in amanner similar to that shown and described in the embodiment of FIG.3(a). The keypad 204 also includes a dedicated key 212 for interfacingwith and requesting data from the BG monitoring system 20. However, inalternative embodiments, the keypad 204 may include more or less keys ordifferent key arrangements than those illustrated in FIG. 6(c).

[0077] In other alternative embodiments, the relay device 10′″ mayinclude a housing 200′″ with a display 214 and a keypad 216, as shown inFIG. 6(d). In particular alternative embodiments, the display 214 may bea monochromatic liquid crystal display (LCD). In other particularalternative embodiments, the display 214 may be a light emitting diode(LED) display, a cathode ray tube (CRT) display, a touch screen, a colorLCD, or the like. The keypad 216 may include more than one key, and atleast one of the keys may be utilized by the user to send data orcommands to the infusion pump 30. In the illustrated embodiment, thekeypad 216 includes an Up-Arrow key 218, a Down-Arrow key 220, an ACT(activate) key 222, and an ESC (escape) key 224 for programming theinfusion pump 30 from the relay device 10 in a manner similar to thatshown and described in the embodiment of FIG. 3(a). The keypad 216 alsoincludes a dedicated key 226 for interfacing with and requesting datafrom the BG monitoring system 20. However, in alternative embodiments,the keypad 216 may include more or less keys or different keyarrangements than those illustrated in FIG. 6(d). In still otheralternative embodiments, the relay device 10 may be a computer system(not shown), such as a personal computer (PC), a personal digitalassistant (PDA), a central data system (such as is used in hospitals tostore or track data, Internet systems, or the like), or the like.

[0078] In preferred embodiments, the relay device 10 is positioned onthe user's body near the BG monitoring system 20. For example, the relaydevice 10 may be positioned on the user's is body using a necklace 250to hold the relay device 10 like a pendant (as shown in FIG. 7(a)),using a belt or strap 252 to hold the relay device 10 in place (as shownin FIG. 7(b)), or by placing the relay device 10 in a clothing garment254 or clipping the relay device 10 in place (as shown in FIG. 7(c)).Positioning the relay device 10 near the BG monitoring system 20 isespecially useful to minimize the power required by the transmitterand/or receiver in the BG monitoring system 20 to send and/or receivesignals between the BG monitoring system 20 and the relay device 10.Other methods may be used to locate the relay device 10 near the BGmonitoring system 20, such as using tape or adhesive to hold the relaydevice 10 in place, holding the relay device 10 in a hand and bringingthe hand near the BG monitoring system 20, or the like.

[0079] In alternative embodiments, the relay device 10 may beincorporated with the infusion pump 30 to minimize the number ofcomponents that the user must handle. For example, the relay device 10may be incorporated into a clip that is attached to the infusion pump 30to hold the infusion pump 30 in place on the user's body, as shown inFIG. 8(a). Alternatively, the relay device 10′ may be mounted on a sideof the infusion pump 30, as shown in FIG. 8(b). Additionally, the relaydevice 10″ may be attached to a bottom of the infusion pump 30, as shownin FIG. 8(c). In other alternative embodiments, the relay device 10 maybe incorporated with the BG monitoring system 20 in a manner similar tothat shown and described in the embodiments of FIGS. 8(a)-8(c). Forexample, the relay device 10 may be incorporated into a clip that isattached to, or mounted on a side of, or attached to a bottom of, thedata processor 56 shown in FIGS. 2(a)-2(b) or the glucose monitor 54″shown in FIG. 2(c).

[0080] In further alternative embodiments, the relay device 10 may beincorporated into the infusion pump 30. FIG. 8(d) illustrates a cut-awayperspective view of the infusion pump 30 showing the electronic boardsand modules that may be included in the infusion pump 30. The infusionpump 30 may include a display module 260, a mother board 262, and aninterface board 264. The mother board 262 is the main control unit forthe infusion pump 30, and includes the processor and memory. The displaymodule 260 includes the display 100, and in particular embodiments, abacklight for the display 100. The interface board 264 interfacesbetween different systems in the infusion pump 30, and includes thedrive mechanism and power supplies. The infusion pump 30 also includes acommunication board 265 and an antenna 268, which enable communicationwith external devices, such as a remote programmer (not shown) for theinfusion pump 30, the BG monitoring system 20, and the like. Thecommunication board 265 includes the communication system as well as therelay device components. During communications with the BG monitoringsystem 20, the drive mechanism and power supplies on the interface board264 are temporarily shutdown. Accordingly, the infusion pump 30 furtherincludes a capacitor 266 for providing power to the infusion pump 30 andthe communication board 265 during such communications.

[0081] For example, referring to FIGS. 10-12, the relay device (notshown) may be incorporated into the infusion pump 30. The BG monitoringsystem 20 may transmit communications to the infusion pump 30 in asensor system format, the relay device incorporated into the infusionpump 30 may receive such communications and convert them to a deliverysystem format, and the infusion pump 30 may then process such convertedcommunications. Conversely, the infusion pump 30 may formatcommunications in the delivery system format, the relay deviceincorporated into the infusion pump 30 may convert such communicationsto the sensor system format and transmit such converted communications,and the BG monitoring system 20 may receive such communications in thesensor system format. In particular embodiments, the BG monitoringsystem 20 may communicate with the infusion pump 30 using wireless modesof communication, such as radio frequency (RF), infrared (IR),ultrasonic, sonic, optical, and the like, as shown in FIGS. 10 and 11.In other particular embodiments, the BG monitoring system 20 maycommunicate with the infusion pump 30 using a wired connection 35, asshown in FIG. 12.

[0082] In particular embodiments, information may be downloaded directlyfrom the relay device 10 to a storage media through an interface, suchas a transmitter, a cable, a communication station, or the like. Forexample, information stored by the BG monitoring system 20 and/or theinfusion pump 30 may be transmitted to the relay device 10, and thendownloaded from the relay device 10 to the storage media. The storagemedia may include one or more of a personal computer (PC), a centralserver, an electronic memory, a personal digital assistant (PDA), a cellphone, a laptop computer, magnetic memory, silicon memory, a datastorage device, and the like. In alternative embodiments, informationmay be downloaded directly from the BG monitoring system 20 or theinfusion pump 30 to a storage media. In further alternative embodiments,information may be downloaded to the storage media from more than one ofthe BG monitoring system 20, relay device 10, and infusion pump 30.

[0083] In preferred embodiments, the relay device 10 communicates withthe BG monitoring system 20 and the infusion pump 30 using radiofrequency (RF) communication. In alternative embodiments, other modes ofcommunication may be used, such as infrared (IR), wired, ultrasonic,sonic, optical, and the like. In further alternative embodiments, morethan one mode of communication may be utilized by the relay device 10.

[0084] In preferred embodiments, the relay device 10 includes an RFmixer 300, a first microcontroller 302, a second microcontroller 304,and an RF transceiver 306, as shown in FIG. 9(a). The RF mixer 300receives an RF signal from the BG monitoring system 20 and forwards thesignal to the first microcontroller 302. The first microcontroller 302decodes the RF signal received in a first format from the BG monitoringsystem 20 (e.g., at a frequency of 131 kilohertz), and forwards thedecoded signal to the second microcontroller 304. Next, the secondmicrocontroller 304 processes and encodes the signal into a secondformat for the infusion pump 30 (e.g., at a frequency of 916 megahertz),and forwards the encoded signal to the RF transceiver 306. The RFtransceiver 306 then transmits the encoded signal to the infusion pump30. Conversely, the RF transceiver 306 receives an RF signal from theinfusion pump 30 and forwards the signal to the second microcontroller304. The second microcontroller 304 decodes the RF signal received inthe second format from the infusion pump 30, and forwards the decodedsignal to the first microcontroller 302. Next, the first microcontroller302 processes and encodes the signal into the first format for the BGmonitoring system 20, and forwards the encoded signal to the RF mixer300. The RF mixer 300 then transmits the encoded signal to the BGmonitoring system 20. Inclusion of the two microcontrollers 302 and 304allows the relay device 10 to encode and decode signals for the BGmonitoring system 20 and the infusion pump 30 simultaneously.

[0085] In alternative embodiments, the two microcontrollers 302 and 304shown in FIG. 9(a) may be replaced with a single fast microcontroller308, as illustrated in FIG. 9(b). The fast microcontroller 308 encodesand decodes signals in appropriate formats respectively for the BGmonitoring system 20 and the infusion pump 30 in a manner similar tothat of the two microcontrollers 302 and 304 shown in FIG. 9(a). Infurther alternative embodiments, the relay device 10″ may include an RFmixer 320 and an RF transceiver 326, as illustrated in FIG. 9(c), whichare similar to the RF mixer 300 and RF transceiver 306 shown in FIGS.9(a) and 9(b). The relay device 10″ may also include a fieldprogrammable gate array (FPGA) 322, which performs functions similar tothe first microcontroller 302 shown in FIG. 9(a), for encoding anddecoding signals in an appropriate format for the BG monitoring system20. The relay device 10″ may further include a microcontroller 322,which is similar to the second microcontroller 304 shown in FIG. 9(a),for encoding and decoding signals in an appropriate format for theinfusion pump 30.

[0086] In other alternative embodiments, the relay device 10′″ mayinclude an application specific integrated circuit (ASIC) 340, whichincorporates an RF mixer for transmitting and receiving signals to andfrom the BG monitoring system 20, as illustrated in FIG. 9(d). The ASIC340 may also encode and decode information in an appropriate format forthe BG monitoring system 20. Additionally, the relay device 10′″ mayinclude a microcontroller 342, which is similar to the secondmicrocontroller 304 shown in FIG. 9(a), for encoding and decodingsignals in an appropriate format for the infusion pump 30. The relaydevice 10′″ may further include an RF transceiver 344, which is similarto the RF transceiver 306 shown in FIG. 9(a), for transmitting andreceiving signals to and from the infusion pump 30. In still otheralternative embodiments, the microcontroller 342 shown in FIG. 9(d) maybe omitted, and the functionality instead may be included in anapplication specific integrated circuit (ASIC_360, as shown in FIG.9(e). The ASIC 360 transmits and receives signals to and from the BGmonitoring system 20. The ASIC 360 also encodes and decodes signals inappropriate formats respectively for the BG monitoring system 20 andinfusion pump 30. The relay device 10″″ may further include an RFtransceiver 362, which is similar to the RF transceiver 306 shown inFIG. 9(a), for transmitting and receiving signals to and from theinfusion pump 30.

[0087] Referring to FIG. 1, the relay device 10 receives informationfrom the BG monitoring system 20 in a sensor system format, converts theinformation into a delivery system format appropriate for the infusionpump 30, and then transmits the converted information in the deliverysystem format to the infusion pump 30. The relay device 10 may alsoreceive information from the infusion pump 30 in the delivery systemformat, convert the information into the sensor system formatappropriate for the BG monitoring system 20, and then transmit theconverted information in the sensor system format to the BG monitoringsystem 20. In alternative embodiments, communication is in only onedirection, either from the BG monitoring system 20 to the infusion pump30, or from the infusion pump 30 to the BG monitoring system 20.

[0088] In preferred embodiments, the sensor system and delivery systemformats include one or more frequencies, communication protocols, andthe like that are used to transfer information between the BG monitoringsystem 20 and the infusion pump 30. For example, the sensor systemformat utilized by the BG monitoring system 20 may include a lowerfrequency, such as 131 kilohertz, resulting in less tissue attenuationat and/or near the insertion site of the BG monitoring sensor set 50.The delivery system format utilized by the infusion pump 30 may includea higher frequency, such as 916 megahertz or 402-405 megahertz, ensuringcompliance with federal, state, regulatory, and other requirements forRF communications. However, other frequencies may be utilized by the BGmonitoring system 20 and/or infusion pump 30.

[0089] The communication protocols specify carrier media forcommunication, such as radio frequency (RF) (including frequencymodulated (FM), amplitude modulated (AM), and the like RF), infrared(IR), ultrasonic, audio, light wave, Bluetooth, IRDA, conductive usingwires or other direct contacts, and the like. The communicationprotocols also specify information packaging, which includes how theinformation is arranged and sent on the carrier media. For example, theinformation packaging may specify which data components are sent (e.g.,the serial number of the relay device 10, BG monitoring system 20,and/or infusion pump 30, a date and time stamp, a sensor measurement, apump command, and the like). The information packaging may also specifythe order in which data components are sent. Further, the informationpackaging may specify how the information is sent, such as in packets,bits, words, and the like. The information packaging may additionallyspecify how the information is expressed, such as in decimal,hexadecimal, DC balanced format, and the like.

[0090] The BG monitoring system 20 utilizes a sensor systemcommunication protocol, and the infusion pump 30 utilizes a deliverysystem communication protocol. For example, the BG monitoring system 20uses the sensor system communication protocol to communicate with therelay device 10, and the infusion pump 30 uses the delivery systemcommunication protocol to communicate with the relay device 10. Inparticular embodiments, the BG monitoring system 20 and infusion pump 30do not use the same communication protocol; thus, the relay device 10converts information received from the BG monitoring system 20 into thedelivery system communication protocol for communicating to the infusionpump 30, and the relay device 10 converts information received from theinfusion pump 30 into the sensor system communication protocol forcommunicating to the BG monitoring system 20. For example, the relaydevice 10 may receive BG data or measurements from the BG monitoringsystem 20 formatted in the sensor system communication protocolutilizing radio frequency carrier media, in packets of 107 bytes, or thelike. The relay device 10 converts such data or measurements into thedelivery system communication protocol utilizing infrared carrier media,in packets of 71 bytes, or the like, and then transmits such converteddata or measurements formatted in the delivery system communicationprotocol to the infusion pump 30. However, other carrier media orinformation packaging may be utilized by the BG monitoring system 20and/or infusion pump 30.7 In preferred embodiments, the relay device 10,BG monitoring system 20, infusion pump 30, and other devices capable ofcommunicating with the relay device 10, BG monitoring system 20, and/orinfusion pump 30 (e.g., remote programmer for the BG monitoring system20, remote programmer for the infusion pump 30, and the like) each havea unique identification (ID) code, such as a serial number,identification number, password, or the like. The ID code may beincluded in communications transmitted to and received from the relaydevice 10, BG monitoring system 20, and/or infusion pump 30 in order toensure security and/or to distinguish information from various sources.In particular embodiments, each packet of information that istransmitted to the relay device 10 may include the ID code for the relaydevice 10, and the relay device 10 may use the ID code to discernwhether the packet of information is intended for the relay device 10.Similarly, each packet of information that is transmitted to the BGmonitoring system 20 may include the ID code for the BG monitoringsystem 20, and the BG monitoring system 20 may use the ID code todiscern whether the packet of information is intended for the BGmonitoring system 20. Also, each packet of information that istransmitted to the infusion pump 30 may include the ID code for theinfusion pump 30, and the infusion pump 30 may use the ID code todiscern whether the packet of information is intended for the infusionpump 30. In further particular embodiments, the relay device 10, BGmonitoring system 20, infusion pump 30, and other devices capable ofcommunicating with the relay device 10, BG monitoring system 20, and/orinfusion pump 30 may know each other's unique ID code. The BG monitoringsystem 20 and/or the infusion pump 30 may respond to commands and acceptinformation only from devices for which they know such ID codes. Forexample, the BG monitoring system 20 may communicate with the infusionpump 30 through the relay device 10, and thus, may know the ID codes forthe relay device 10 and infusion pump 30. Conversely, the infusion pump30 may communicate with the BG monitoring system 20 through the relaydevice 10, and thus, may know the ID codes for the relay device 10 andBG monitoring system 20. The infusion pump 30 may also know the ID codefor a remote programmer. In alternative embodiments, the relay device10, BG monitoring system 20, infusion pump 30, and other devices capableof communicating with the BG monitoring system 20 and/or infusion pump30 have no ID code.

[0091] In preferred embodiments, the BG monitoring system 20 iscontinually synchronized with any device that communicates with the BGmonitoring system 20, such as the relay device 10, the infusion pump 30via the relay device 10, and the like. The BG monitoring system 20transmits information at fixed intervals (e.g., once every thirtyseconds, minute, five minutes, ten minutes, twenty minutes, or the like)for exact time periods (e.g., for time periods of less than one second,one second, one to five seconds, more than five seconds, or the like).The devices that communicate with the BG monitoring system 20 “wake up”at the fixed intervals and “listen” to receive the information from theBG monitoring system 20. This fixed interval communication method allowsthe BG monitoring system 20 and the devices that communicate with the BGmonitoring system 20 to supply power to their communication systems on aperiodic, rather than continuous, basis. Accordingly, the BG monitoringsystem 20 and the devices that communicate with the BG monitoring system20 are able to save power when not communicating with one another. Inalternative embodiments, the BG monitoring system 20 and the devicesthat communicate with the BG monitoring system 20 may supply power totheir communication systems on a continuous basis, and thus, be capableof continuous communication. In further alternative embodiments, the BGmonitoring system 20 and the devices that communicate with the BGmonitoring system 20 may supply power to their communication systemsonly upon request from the user. For example, the user may select thededicated key 122 on the infusion pump 30 shown in FIG. 3(a), oralternatively, the dedicated key 212 or 226 on the relay device 10 shownin FIGS. 6(c) and 6(d), to request information from the BG monitoringsystem 20. The BG monitoring system 20 may periodically supply power toits communication system for a relatively short time period in order todetect whether another device is requesting information, and in responseto such a request, the BG monitoring system 20 and the devices thatcommunicate with the BG monitoring system 20 may supply power to theircommunication systems and then communicate the requested information.Accordingly, the BG monitoring system 20 and the devices thatcommunicate with the BG monitoring system 20 are able to save power whennot communicating with one another.

[0092] Referring to FIG. 1, the relay device 10 receives informationfrom the BG monitoring system 20, and then transmits the information tothe infusion pump 30. The relay device 10 may also receive informationfrom the infusion pump 30, and then transmit the information to the BGmonitoring system 20. In preferred embodiments, the infusion pump 30includes a display 32 and a user interface 34, as shown in FIG. 4(a).For example, the display 32 may be an LCD display 100, and the userinterface 34 may be a keypad 10 including one or more keys, as shown inFIGS. 3(a)-3(b). The BG monitoring system 20 sends a sensor signal tothe relay device 10, and then the relay device 10 sends the sensorsignal to the infusion pump 30. In preferred embodiments, the sensorsignal contains uncalibrated sensor data, and the infusion pump 30calibrates the uncalibrated sensor data to generate sensor measurements,which are shown on the display 32. In particular embodiments, the BGmonitoring system automatically sends the sensor data to the infusionpump 30 on a periodic (e.g., once every thirty seconds, minute, fiveminutes, ten minutes, or the like) or continuous basis, and the infusionpump 30 automatically shows the sensor measurement on the display 32once the sensor data has been received and calibrated. The user may alsoutilize the user interface 34 to cause the display 32 to show a sensormeasurement. In other particular embodiments, once the infusion pump 30generates the sensor measurement, the infusion pump 30 may provide analarm or warning to the user if the sensor measurement is above or belowtarget glycemic values. For example, if the sensor measurement is abovea hyperglycemic limit (e.g., 250 mg/dl) or below a hypoglycemic limit(e.g., 70 mg/dl), the infusion pump 30 may provide the user with avisible alarm via the display 100 and/or lights, an audible alarm viathe speaker 156, and/or a vibration alarm via the vibrator 158. Theinfusion pump 30 may also suspend insulin delivery if the sensormeasurement is below the hypoglycemic limit, and notify the user toactivate a bolus delivery if the sensor measurement is above thehyperglycemic limit. In further particular embodiments, the infusionpump 30 may include the bolus estimator 164, which utilizes the sensormeasurement to estimate an appropriate amount of insulin to be deliveredto the user based on the user's BG level, the amount of carbohydrates tobe consumed, and the like. The calculated bolus estimate may be shown tothe user on the display 32, and the user may then utilize the userinterface 34 to accept or modify the bolus estimate for infusion intothe user. In alternative embodiments, the BG monitoring system 20calibrates the sensor data to generate sensor measurements, which areincluded in the sensor signal transmitted from the BG monitoring system20 to the infusion pump 30 via the relay device 10. In other alternativeembodiments, the BG monitoring system 20 sends a sensor signal withuncalibrated sensor data to the relay device 10, the relay device 10calibrates the uncalibrated sensor data to generate sensor measurements,and the relay device 10 sends the sensor signal with the sensormeasurements to the infusion pump 30.

[0093] In additional alternative embodiments, the infusion pump 30 mayinclude a display 32, and the relay device 10 may include a userinterface 14, as shown in FIG. 4(b). For example, the display 32 may bean LCD display 100 (as shown in FIGS. 3(a)-3(b)), and the user interface14 may be a single key 202 (as shown in FIG. 6(b)), or a keypad 204 or216 including one or more keys (as shown in FIGS. 6(c) and 6(d)). Theuser may utilize the user interface 14 on the relay device 10 to requestnew data from the BG monitoring system 20. When the user interface 14 isactivated (e.g., the user presses the single key 202 shown in FIG. 6(b),one or more keys on the keypad 204 shown in FIG. 6(c), or one or morekeys on the keypad 216 shown in FIG. 6(d)), the relay device 10 sends arequest to the BG monitoring system 20 to transmit the most recentsensor data, as shown in FIG. 4(b). In other alternative embodiments,when the user interface 14 is activated, the relay device 10 sends asignal to the infusion pump 30 to request the most recent sensor datafrom the BG monitoring system 20, and the infusion pump 30 then sendssuch a request to the BG monitoring system 20 through the relay device10, as shown in FIG. 4(c). Referring to FIGS. 4(b) and 4(c), in responseto a request for the most recent sensor data, the BG monitoring system20 sends a sensor signal to the relay device 10, and then the relaydevice 10 sends the sensor signal to the infusion pump 30, similar tothe manner described above with respect to FIG. 4(a). In particularembodiments, the infusion pump 30 may automatically show a sensormeasurement on the display 32 once the sensor signal is received by theinfusion pump 30. The user may also utilize the user interface 14 on therelay device 10 to cause the display 32 on the infusion pump 30 to showa sensor measurement. The user may also utilize the user interface 14 onthe relay device 10 to send commands or data to the infusion pump 30.

[0094] In further alternative embodiments, the relay device 10 mayinclude a first user interface 14′, and the infusion pump 30 may includea display 32 and a second user interface 34′, as shown in FIG. 4(f). Theuser may utilize the first user interface 14′ on the relay device 10 torequest new data from the BG monitoring system 20. When the first userinterface 14′ is activated, the relay device 10 sends a request to theBG monitoring system 20 to transmit the most recent sensor data. Inresponse, the BG monitoring system 20 sends a sensor signal to the relaydevice 10, and then the relay device 10 sends the sensor signal to theinfusion pump 30, similar to the manner described above with respect toFIG. 4(a). In particular embodiments, the infusion pump 30 mayautomatically show a sensor measurement on the display 32′ once thesensor signal is received by the infusion pump 30. The user may alsoutilize the first user interface 14′ on the relay device 10 or thesecond user interface 34′ on the infusion pump 30 to cause the display32 on the infusion pump 30 to show a sensor measurement. The user mayadditionally utilize the first user interface 14′ on the relay device 10to send commands or data to the infusion pump 30. Further, the user mayutilize the second user interface 34′ on the infusion pump 30 to performfunctions on the infusion pump 30.

[0095] In other alternative embodiments, the relay device 10 may includea display 12 and a user interface 14, as shown in FIG. 4(d). Forexample, the display 12 may be an LCD display 214, and the userinterface 14 may be a keypad 216 including one or more keys, asillustrated in FIG. 6(d). The BG monitoring system 20 sends a sensorsignal with uncalibrated sensor data to the relay device 10, and therelay device 10 calibrates the data to generate sensor measurements,which are shown on the display 12 of the relay device 10. In particularembodiments, the relay device 10 may automatically show a sensormeasurement on the display 12 once the sensor data is received andcalibrated by the relay device 10. The user may also utilize the userinterface 14 to cause the display 12 to show a sensor measurement. Theuser may further utilize the user interface 14 on the relay device 10 tosend commands or data to the infusion pump 30. In particularembodiments, the relay device 10 may also receive data from the infusionpump 30 (not shown), such as the amount of insulin remaining, alarmsindicating a low battery or no delivery by the infusion pump 30, and thelike. The relay device 10 may then utilize such data to adjust thecommands sent to the infusion pump 30 and/or show such data on thedisplay 12 to the user. In alternative embodiments, the BG monitoringsystem 20 calibrates the sensor data to generate sensor measurements,which are included in the sensor signal transmitted from the BGmonitoring system 20 to the relay device 10.

[0096] In still other alternative embodiments, the BG monitoring system20 includes a display 22 and a user interface 24, as shown in FIG. 4(e).For example, the display 22 may be an LCD display 58, and the userinterface 24 may be a keypad 60 including one or more keys, as shown inFIGS. 2(a)-2(c). The BG monitoring system 20 calibrates the sensor datato generate sensor measurements, which are shown on the display 22 ofthe BG monitoring system 20. In particular embodiments, the BGmonitoring system 20 may automatically show a sensor measurement on thedisplay 22 once the sensor data is calibrated. The user may also utilizethe user interface 24 to cause the display 22 to show a sensormeasurement. The user may further utilize the user interface 24 on theBG monitoring system 20 to send commands or data through the relaydevice 10 to the infusion pump 30.

[0097] In preferred embodiments, the BG monitoring system 20 sends asensor signal to the relay device 10, and then the relay device 10 sendsthe sensor signal to the infusion pump 30, as shown in FIG. 4(a). Theinfusion pump 30 includes a display 32 and a user interface 34, such asthe display 100 and user interface 110 shown in FIG. 3(a). In particularembodiments, the BG monitoring system automatically sends the sensorsignal to the infusion pump 30 on a periodic (e.g., once every thirtyseconds, minute, five minutes, ten minutes, or the like) or continuousbasis. In other particular embodiments, the infusion pump 30periodically sends a command signal to the BG monitoring system 20 viathe relay device 10, commanding the BG monitoring system 20 to send thesensor signal to the infusion pump 30, and in response to the command,the BG monitoring system 20 sends the sensor signal to the infusion pump30. In further particular embodiments, the user interface 110 may beutilized to cause the BG monitoring system 20 to send the sensor signalto the infusion pump 30 via the relay device 10. In preferredembodiments, the infusion pump 30 automatically shows a sensormeasurement on the display 32 once the sensor signal is received by theinfusion pump 30. The user may also utilize the user interface 110 tocause the display 100 to show a sensor measurement.

[0098] The user interface 110 on the infusion pump 30 preferablyincludes a dedicated interface for requesting information from and/orinputting data to the BG monitoring system 20 via the relay device 10.Additionally, in particular embodiments where bidirectionalcommunication is not enabled continuously between the BG monitoringsystem 20 and the infusion pump 30, utilizing the dedicated interfacemay initiate bi-directional communication between the infusion pump 30and the BG monitoring system 20 via the relay device 10. In furtherparticular embodiments, the dedicated interface may be used to cause thedisplay 100 of the infusion pump 30 to show historical data, such astrends of whether sensor measurements are increasing or decreasing, aplot of two or more sensor measurements, a graph of the past n-hours ofsensor measurements, and the like. In other embodiments, the infusionpump 30 may automatically show sensor measurements or historical data(e.g., trends, plots, graphs, or the like of sensor measurements) on thedisplay 100 when the display 100 would otherwise be blank.

[0099] Referring to FIG. 3(a), the dedicated interface on the infusionpump 30 may include a dedicated key 122 for causing the display 100 toshow the sensor measurement. In alternative embodiments, the user mayselect one or more keystrokes to cause the display 100 to show thesensor measurement. For example, the user may select the dedicated key122 followed by the ACT key 116 to cause the display 100 to show thesensor measurement. In further alternative embodiments, the ability ofthe infusion pump 30 to communicate with the BG monitoring system 20 viathe relay device 10 may be activated by entering the BG monitoringsystem's 20 serial number or other identifying information into theinfusion pump 30. In response, the infusion pump 30 may program certainkeys for interfacing with the BG monitoring system 20 via the relaydevice 10.

[0100] In other alternative embodiments, the dedicated interface mayinclude a button, switch, lever, handle, touch screen, or the like, orcombinations of keys, buttons, switches, levers, handles, touch screens,or the like. Combinations of interfaces include activating more than oneinterface simultaneously (in parallel), or activating more than oneinterface in sequence. In still other alternative embodiments, thededicated interface may be located on another device that communicateswith the infusion pump 30, and the sensor measurement may be shown on adisplay of that device, such as the BG monitoring system 20 (forexample, the glucose monitor 54 and/or data processor 56), a remoteprogrammer (not shown) for the infusion pump 30, a personal digitalassistant (PDA), a computer, a cell phone, or the like.

[0101] In preferred embodiments, one or more sensor measurements arestored in the memory 154 of the infusion pump 30. Furthermore, selectingthe dedicated key 122 (or other dedicated interface) causes the mostrecent sensor measurement to be shown on the display 100. When the mostrecent sensor measurement is already shown on the display 100, selectingthe dedicated key 122 causes the next, most recent sensor measurement tobe shown on the display 100, and each subsequent selection of thededicated key 122 causes older and older sensor measurements to be shownon the display 100. In alternative embodiments, the infusion pump 30 mayinclude other user interfaces to display older sensor measurements. Inother alternative embodiments, the sensor measurements may be stored ina storage device other than the infusion pump 30, and selecting thededicated key 122 causes the infusion pump 30 to retrieve the sensormeasurement from the storage device and then show it on the display 100.

[0102] In additional alternative embodiments, the infusion pump 30periodically sends a command signal to the BG monitoring system 20 viathe relay device 10, commanding the BG monitoring system 20 to sendsensor data to the infusion pump 30, so that the most recent sensor datais available to be shown on the display 100 of the infusion pump 30. Inresponse to the command from the infusion pump 30, the BG monitoringsystem 20 sends the sensor data to the infusion pump 30, and theinfusion pump 30 calibrates the sensor data to generate a sensormeasurement. The sensor measurement is then stored in the memory 154 ofthe infusion pump 30. When the user desires to see the most recentsensor measurement, the user selects the dedicated key 122 (orother)dedicated interface) to retrieve the sensor measurement from thememory 154 of the infusion pump 30 and show the sensor measurement onthe display 100 of the infusion pump 30. In other alternativeembodiments, the sensor data is stored in the memory 154 of the infusionpump 30. When the user selects the dedicated key 122 to view the sensormeasurement, the sensor data is retrieved from the memory 154 of theinfusion pump 30, and then calibrated to generate the sensormeasurement. In further alternative embodiments, the BG monitoringsystem 20 sends calibrated sensor measurements to be stored in thememory 154 of the infusion pump 30. In yet other alternativeembodiments, the infusion pump 30 communicates with the BG monitoringsystem 20 to indicate that the sensor data has been received and/or toecho the sensor data so that the data can be retransmitted if it wasreceived inaccurately.

[0103] In still other alternative embodiments, the dedicated key 122 (orother dedicated interface) is used to cause the BG monitoring system 20to send the most recent sensor data, such as one or more raw sensor datapoints, one or more calibrated sensor measurements, or the like, to theinfusion pump 30. Once the sensor data is received, the infusion pump 30shows the most recent sensor measurement on the display 100. Inparticular alternative embodiments, the infusion pump 30 indicates tothe BG monitoring system 20 the most recent sensor data that theinfusion pump 30 has received, and in response, the BG monitoring system20 sends any additional sensor data that the BG monitoring system 20 hasthat has not been received by the infusion pump 30.

[0104] In another embodiment of the present invention, the BG levelmeasured by the BG monitoring system 20 is used in a closed loopalgorithm to automatically adjust the delivery of fluid, such asinsulin, in the infusion pump 30. A calibration algorithm is used toconvert sensor data into sensor measurements, and then the sensormeasurements are used in a closed loop algorithm to generate fluiddelivery commands to operate the infusion pump 30. In particularembodiments, the calibration algorithm 26 and closed loop algorithm 28reside with and are executed by the processor of the BG monitoringsystem 20, as shown in FIG. 5(a). Commands to control the infusion pump30 are generated at the BG monitoring system 20, and are sent throughthe relay device 10 to the infusion pump 30.

[0105] In other particular embodiments, the calibration algorithm 26resides with and is executed by the processor of the BG monitoringsystem 20, and the closed loop algorithm 18 resides with and is executedby the processor of the relay device 10, as shown in FIG. 5(b).Calibrated sensor measurements are sent from the BG monitoring system 20to the relay device 10, and fluid delivery commands are sent from therelay device to the infusion pump 30.

[0106] In still other particular embodiments, the calibration algorithm26 resides with and is executed by the processor of the BG monitoringsystem 20, and the closed loop algorithm 38 resides with and is executedby the processor of the infusion pump 30, as shown in FIG. 5(c).Calibrated sensor measurements are sent from the BG monitoring system 20through the relay device 10 to the infusion pump 30, and fluid deliverycommands are generated at the infusion pump 30.

[0107] In yet other particular embodiments, the calibration algorithm 16and the closed loop algorithm 18 both reside with and are executed bythe processor of the relay device 10, as shown in FIG. 5(d).Uncalibrated sensor data is sent from the BG monitoring system 20 to therelay device 10, where they are calibrated and used in the closed loopalgorithm 18 to generate fluid delivery commands, which are sent to theinfusion pump 30.

[0108] In further particular embodiments, the calibration algorithm 16resides with and is executed by the processor of the relay device 10,and the closed loop algorithm 38 resides with and is executed by theprocessor of the infusion pump 30, as shown in FIG. 5(e). Uncalibratedsensor data is sent from the BG monitoring system 20 to the relay device10, where they are calibrated to generate sensor measurements. Then thesensor measurements are sent to the infusion pump 30 and used in theclosed loop algorithm 38 to generate fluid delivery commands.

[0109] In additional particular embodiments, the calibration algorithm36 and the closed loop algorithm 38 both reside with and are executed bythe processor of the infusion pump 30, as shown in FIG. 5(f).Uncalibrated sensor data is sent from the BG monitoring system 20through the relay device 10 to the infusion pump 30. Then, at theinfusion pump 30, the uncalibrated sensor data is calibrated and used inthe closed loop algorithm 38 to generate fluid delivery commands.

[0110] In alternative embodiments, a semi-closed loop algorithm is usedin place of a closed loop algorithm. A semi-closed loop algorithmgenerates recommended changes to the fluid delivery, which must beapproved by the user or a caregiver using the user interface on theinfusion pump 30, the BG monitoring system 20, or the relay device 10before new commands are issued to the infusion pump 30.

[0111] Although FIGS. 4(a)-5(f) generally show communication flowingfrom the BG monitoring system 20 to the infusion pump 30, it should benoted that communication signals might be generated by any of thedevices. In particular embodiments, a signal may be sent from theinfusion pump 30 through the relay device 10 to the BG monitoring system20. The signals from the infusion pump 30 may include signals to requestinformation from the BG monitoring system 20, verify receipt ofinformation, echo information received, transmit information to bedownloaded to the BG monitoring system 20, and the like. In additionalalternative embodiments, signals may be initiated at the relay device 10and sent to the BG monitoring system 20 and/or the infusion pump 30.

[0112] While the description above refers to particular embodiments ofthe present invention, it will be understood that many modifications maybe made without departing from the spirit thereof. The accompanyingclaims are intended to cover such modifications as would fall within thetrue scope and spirit of the present invention.

[0113] The presently disclosed embodiments are therefore to beconsidered in all respects as illustrative and not restrictive, thescope of the invention being indicated by the appended claims, ratherthan the foregoing description, and all changes which come within themeaning and range of equivalency of the claims are therefore intended tobe embraced therein.

What is claimed is:
 1. An infusion system for infusing a fluid into auser, the infusion system comprising: a sensor system including: asensor system housing; a sensor coupled to the sensor system housing forproducing a signal indicative of a physiological characteristic level ofthe user; a sensor system processor contained in the sensor systemhousing for processing the signal indicative of the physiologicalcharacteristic level of the user; and a sensor system transmittercontained in the sensor system housing and coupled to the sensor systemprocessor for transmitting one or more communications in a sensor systemformat; a relay device including: a relay device receiver for receivingthe communications from the sensor system in the sensor system format; arelay device processor for processing the communications from the sensorsystem and converting the communications for transmission in a deliverysystem format; and a relay device transmitter for transmitting theconverted communications in the delivery system format; and a fluiddelivery system including: a delivery system housing; a delivery systemreceiver contained in the delivery system housing for receiving thecommunications from the relay device in the delivery system format; anda delivery system processor contained in the delivery system housing andcoupled to the delivery system receiver for processing thecommunications from the relay device in the delivery system format andcontrolling an amount of the fluid infused into the user; wherein theamount of the fluid infused into the user is determined based upon dataindicative of the physiological characteristic level of the userobtained by the sensor system.
 2. The infusion system according to claim1, wherein at least one of the communications transmitted from thesensor system through the relay device and received by the fluiddelivery system include data indicative of the physiologicalcharacteristic level of the user.
 3. The infusion system according toclaim 2, wherein the communications including the data indicative of thephysiological characteristic level of the user are automaticallytransmitted from the sensor system through the relay device and receivedby the fluid delivery system.
 4. The infusion system according to claim3, wherein the fluid delivery system further includes a display devicecontained in the delivery system housing and coupled to the deliverysystem processor for automatically displaying to the user the dataindicative of the physiological characteristic level of the user.
 5. Theinfusion system according to claim 3, wherein the fluid delivery systemfurther includes: a display device contained in the delivery systemhousing and coupled to the delivery system processor for displaying datato the user; and a user interface contained in the delivery systemhousing and coupled to the delivery system processor for accepting oneor more inputs from the user, wherein at least one of the inputs causesthe display device to display the data indicative of the physiologicalcharacteristic level of the user received by the fluid delivery system.6. The infusion system according to claim 5, wherein at least a portionof the user interface is dedicated for interfacing with the dataindicative of the physiological characteristic level of the userreceived by the fluid delivery system.
 7. The infusion system accordingto claim 3, wherein the fluid delivery system further includes a memorycontained in the delivery system housing for storing the data indicativeof the physiological characteristic level of the user received by thefluid delivery system.
 8. The infusion system according to claim 7,wherein the fluid delivery system further includes a display devicecontained in the delivery system housing and coupled to the deliverysystem processor for displaying to the user a historical trend or graphusing the stored data indicative of the physiological characteristiclevel of the user received by the fluid delivery system.
 9. The infusionsystem according to claim 7, wherein the fluid delivery system furtherincludes: a display device contained in the delivery system housing andcoupled to the delivery system processor for displaying data to theuser; and a user interface contained in the delivery system housing andcoupled to the delivery system processor for accepting one or moreinputs from the user, wherein at least one of the inputs causes thedisplay device to display the most recent data indicative of thephysiological characteristic level of the user received by the fluiddelivery system.
 10. The infusion system according to claim 9, whereinat least another one of the inputs causes the display device to displaythe next most recent data indicative of the physiological characteristiclevel of the user received by the fluid delivery system.
 11. Theinfusion system according to claim 9, wherein at least a portion of theuser interface is dedicated for interfacing with the data indicative ofthe physiological characteristic level of the user received by the fluiddelivery system.
 12. The infusion system according to claim 9, whereinat least another one of the inputs causes the display device to displaythe stored data that is older than the most recent data indicative ofthe physiological characteristic level of the user received by the fluiddelivery system.
 13. The infusion system according to claim 2, whereinthe fluid delivery system further includes: a display device containedin the delivery system housing and coupled to the delivery systemprocessor for displaying data to the user; and a user interfacecontained in the delivery system housing and coupled to the deliverysystem processor for accepting one or more inputs from the user, whereinat least one of the inputs causes the display device to display the dataindicative of the physiological characteristic level of the userreceived by the fluid delivery system.
 14. The infusion system accordingto claim 13, wherein at least a portion of the user interface isdedicated for interfacing with the data indicative of the physiologicalcharacteristic level of the user received by the fluid delivery system.15. The infusion system according to claim 2, wherein the fluid deliverysystem further includes a user interface contained in the deliverysystem housing and coupled to the delivery system processor foraccepting one or more inputs from the user, wherein at least one of theinputs programs the amount of the fluid infused into the user based uponthe data indicative of the physiological characteristic level of theuser received by the fluid delivery system.
 16. The infusion systemaccording to claim 2, wherein the fluid delivery system furtherincludes: a bolus estimator used in conjunction with the delivery systemprocessor for estimating the amount of the fluid to be infused into theuser based upon the data indicative of the physiological characteristiclevel of the user received by the fluid delivery system; an indicationdevice coupled to the bolus estimator for indicating the estimatedamount of fluid to be infused into the user; and a user interface foraccepting one or more inputs from the user, wherein at least one of theinputs accepts or modifies the estimated amount of the fluid to beinfused into the user.
 17. The infusion system according to claim 2,wherein the fluid delivery system further includes a closed loopalgorithm executed by the delivery system processor for automaticallydetermining the amount of the fluid to be infused into the user basedupon the data indicative of the physiological characteristic level ofthe user received by the fluid delivery system and causing the fluiddelivery system to infuse the determined amount of the fluid into theuser.
 18. The infusion system according to claim 2, wherein the fluiddelivery system further includes an indication device for indicatingwhen the data indicative of the physiological characteristic level ofthe user received by the fluid delivery system is above or below atarget characteristic value.
 19. The infusion system according to claim2, wherein the fluid delivery system further includes: a delivery systemtransmitter contained in the delivery system housing and coupled to thedelivery system processor for transmitting one or more communications inthe delivery system format, wherein the relay device receiver furtherreceives the communications from the fluid delivery system in thedelivery system format, the relay device processor processes thecommunications from the fluid delivery system and converts thecommunications for transmission in the sensor system format, and therelay device transmitter transmits the converted communications in thesensor system format, and wherein the sensor system further includes asensor system receiver contained in the sensor system housing andcoupled to the sensor system processor for receiving the communicationsfrom the relay device in the sensor system format.
 20. The infusionsystem according to claim 19, wherein the fluid delivery system furtherincludes: a display device contained in the delivery system housing andcoupled to the delivery system processor for displaying data to theuser; and a user interface contained in the delivery system housing andcoupled to the delivery system processor for accepting one or moreinputs from the user, wherein at least one of the inputs generates arequest for the data indicative of the physiological characteristiclevel of the user from the sensor system, wherein at least one of thecommunications transmitted from the fluid delivery system through therelay device to the sensor system includes the request, wherein at leastone of the communications including the data indicative of thephysiological characteristic level of the user is transmitted from thesensor system through the relay device and received by the deliverysystem in response to the request, and wherein the display devicedisplays the data indicative of the physiological characteristic levelof the user received by the fluid delivery system.
 21. The infusionsystem according to claim 20, wherein at least a portion of the userinterface is dedicated for interfacing from the fluid delivery systemwith the sensor system through the relay device.
 22. The infusion systemaccording to claim 20, wherein the requested data is the most recentdata indicative of the physiological characteristic level of the userreceived by the fluid delivery system.
 23. The infusion system accordingto claim 20, wherein the fluid delivery system further includes a memorycontained in the delivery system housing for storing the data indicativeof the physiological characteristic level of the user received by thefluid delivery system.
 24. The infusion system according to claim 23,wherein at least another one of the inputs causes the display device todisplay a historical trend or graph using the stored data indicative ofthe physiological characteristic level of the user received by the fluiddelivery system.
 25. The infusion system according to claim 2, whereinthe data indicative of the physiological characteristic level of theuser received by the fluid delivery system is uncalibrated data, and thefluid delivery system further includes a calibration algorithm executedby the delivery system processor for calibrating the uncalibrated datato generate one or more measurements indicative of the physiologicalcharacteristic level of the user.
 26. The infusion system according toclaim 2, wherein the data indicative of the physiological characteristiclevel of the user received by the fluid delivery system includes one ormore measurements indicative of the physiological characteristic levelof the user.
 27. The infusion system according to claim 26, wherein thesensor system further includes a calibration algorithm executed by thesensor system processor for calibrating the signal indicative of thephysiological characteristic level of the user to generate the one ormore measurements indicative of the physiological characteristic levelof the user, and the communications transmitted from the sensor systemthrough the relay device and received by the fluid delivery systeminclude the one or more measurements indicative of the physiologicalcharacteristic level of the user.
 28. The infusion system according toclaim 26, wherein the data indicative of the physiologicalcharacteristic level of the user received from the sensor system by therelay device is uncalibrated data, and the relay device further includesa calibration algorithm executed by the relay device processor forcalibrating the uncalibrated data to generate one or more measurementsindicative of the physiological characteristic level of the user,wherein the communications transmitted from the relay device andreceived by the fluid delivery system include the one or moremeasurements indicative of the physiological characteristic level of theuser.
 29. The infusion system according to claim 2, wherein the dataindicative of the physiological characteristic level of the userreceived by the fluid delivery system is downloadable to an externalstorage device.
 30. The infusion system according to claim 2, whereinthe fluid delivery system further includes a memory contained in thedelivery system housing for storing the data indicative of thephysiological characteristic level of the user received by the fluiddelivery system.
 31. The infusion system according to claim 1, whereinat least one of the communications transmitted from the sensor systemthrough the relay device and received by the delivery system includesone or more commands for programming the amount of the fluid infusedinto the user based upon the data indicative of the physiologicalcharacteristic level of the user.
 32. The infusion system according toclaim 31, wherein the sensor system further includes: a display devicecoupled to the sensor system processor for displaying data to the user;and a user interface coupled to the sensor system processor foraccepting one or more inputs from the user, wherein at least one of theinputs causes the display device to display the data indicative of thephysiological characteristic level of the user obtained by the sensorsystem.
 33. The infusion system according to claim 32, wherein at leastanother one of the inputs generates the one or more commands forprogramming the amount of the fluid infused into the user based upon thedata indicative of the physiological characteristic level of the userobtained by the sensor system.
 34. The infusion system according toclaim 31, wherein the sensor system further includes a closed loopalgorithm executed by the sensor system processor for automaticallygenerating the one or more commands for programming the amount of thefluid to be infused into the user based upon the data indicative of thephysiological characteristic level of the user obtained by the sensorsystem.
 35. The infusion system according to claim 1, wherein at leastone of the communications transmitted from the sensor system to therelay device includes the data indicative of the physiologicalcharacteristic level of the user, and at least one of the communicationstransmitted from the relay device and received by the fluid deliverysystem includes one or more commands for programming the amount of thefluid infused into the user based upon the data indicative of thephysiological characteristic level of the user.
 36. The infusion systemaccording to claim 35, wherein the relay device further includes: adisplay device coupled to the relay device processor for displaying datato the user; and a user interface coupled to the relay device processorfor accepting one or more inputs from the user, wherein at least one ofthe inputs causes the display device to display the data indicative ofthe physiological characteristic level of the user obtained by thesensor system.
 37. The infusion system according to claim 36, wherein atleast another one of the inputs generates the one or more commands forprogramming the amount of the fluid infused into the user based upon thedata indicative of the physiological characteristic level of the userobtained by the sensor system.
 38. The infusion system according toclaim 35, wherein the relay device further includes a closed loopalgorithm executed by the relay device processor for automaticallygenerating the one or more commands for programming the amount of thefluid to be infused into the user based upon the data indicative of thephysiological characteristic level of the user obtained by the sensorsystem.
 39. The infusion system according to claim 1, wherein the sensorsystem format and the delivery system format utilize differentfrequencies for communications transmitted from the sensor systemthrough the relay device and received by the fluid delivery system. 40.The infusion system according to claim 1, wherein the sensor systemformat and the delivery system format utilize different communicationprotocols for communications transmitted from the sensor system throughthe device and received by the fluid delivery system.
 41. The infusionsystem according to claim 40, wherein the different communicationprotocols utilize different carrier media for communications transmittedfrom the sensor system through the relay device and received by thefluid delivery system.
 42. The infusion system according to claim 40,wherein the different communication protocols utilize differentinformation packaging for communications transmitted from the sensorsystem through the relay device and received by the fluid deliverysystem.
 43. The infusion system according to claim 1, wherein thecommunications transmitted from the sensor system through the relaydevice and received by the fluid delivery system are transmitted usingradio frequency communication.
 44. The infusion system according toclaim 1, wherein the communications transmitted from the sensor systemthrough the relay device and received by the fluid delivery system aretransmitted using infrared communication.
 45. The infusion systemaccording to claim 1, wherein the delivery system processor has a uniqueidentification code, and the sensor system processor has the capabilityto learn the unique identification code of the delivery systemprocessor, and further wherein the communications transmitted from thesensor system through the relay device and received by the fluiddelivery system include the unique identification code of the deliverysystem processor to substantially avoid interference with other devices.46. The infusion system according to claim 1, wherein the sensor systemprocessor has a unique identification code, and the delivery systemprocessor has the capability to learn the unique identification code ofthe sensor system processor, and further wherein the communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system include the unique identification code ofthe sensor system processor to substantially avoid interference withother devices.
 47. The infusion system according to claim 1, wherein therelay device processor has a unique identification code, and the sensorsystem processor has the capability to learn the unique identificationcode of the relay device processor, and further wherein thecommunications transmitted from the sensor system to the relay deviceinclude the unique identification code of the relay device processor tosubstantially avoid interference with other devices.
 48. The infusionsystem according to claim 1, wherein the relay device processor has aunique identification code, and the delivery system processor has thecapability to learn the unique identification code of the relay deviceprocessor, and further wherein the communications transmitted from therelay device and received by the fluid delivery system include theunique identification code of the relay device processor tosubstantially avoid interference with other devices.
 49. The infusionsystem according to claim 1, wherein the relay device is coupled to thedelivery system housing.
 50. The infusion system according to claim 1,wherein the relay device is contained in the delivery system housing.51. The infusion system according to claim 1, wherein the relay deviceis coupled to the sensor system housing.
 52. The infusion systemaccording to claim 1, wherein the sensor system is a glucose monitoringsystem, and the fluid delivery system is an insulin infusion device. 53.A relay device for transferring information between a sensor system anda fluid delivery system, wherein the sensor system measures aphysiological characteristic level of a user, and the fluid deliverysystem infuses a fluid into the user, the relay device comprising: asensor system receiver for receiving one or more communications from thesensor system in a sensor system format; a processor for processing thecommunications from the sensor system and converting the communicationsfor transmission in a delivery system format; and a delivery systemtransmitter for transmitting the converted communications in thedelivery system format to the fluid delivery system.
 54. The relayaccording to claim 53, further comprising: a delivery system receiverfor receiving one or more communications from the fluid delivery systemin the delivery system format, wherein the processor further processesthe communications from the fluid delivery system and converts thecommunications for transmission in the sensor system format; and asensor system transmitter for transmitting the converted communicationsin the sensor system format to the sensor system.
 55. The relay deviceaccording to claim 53, wherein at least one of the communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system include data indicative of thephysiological characteristic level of the user.
 56. The relay deviceaccording to claim 53, wherein at least one of the communicationstransmitted from the sensor system through the relay device and receivedby the delivery system includes one or more commands for programming anamount of the fluid to be infused into the user based upon dataindicative of the physiological characteristic level of the userobtained by the sensor system.
 57. The relay device according to claim53, wherein at least one of the communications transmitted from thesensor system to the relay device includes data indicative of thephysiological characteristic level of the user, and at least one of thecommunications transmitted from the relay device and received by thefluid delivery system includes one or more commands for programming anamount of the fluid to be infused into the user based upon the dataindicative of the physiological characteristic level of the user. 58.The relay device according to claim 57, wherein the relay device furtherincludes: a display device coupled to the processor for displaying datato the user; and a user interface coupled to the processor for acceptingone or more inputs from the user, wherein at least one of the inputscauses the display device to display the data indicative of thephysiological characteristic level of the user.
 59. The relay deviceaccording to claim 58, wherein at least another one of the inputsgenerates the one or more commands for programming the amount of thefluid to be infused into the user based upon the data indicative of thephysiological characteristic level of the user.
 60. The relay deviceaccording to claim 53, wherein the sensor system format and the deliverysystem format utilize different frequencies for communicationstransmitted from the sensor system through the relay device to the fluiddelivery system.
 61. The relay device according to claim 53, wherein thesensor system format and the delivery system format utilize differentcommunication protocols for communications transmitted from the sensorsystem through the relay device to the fluid delivery system.
 62. Therelay device according to claim 61, wherein the different communicationprotocols utilize different carrier media for communications transmittedfrom the sensor system through the relay device to the fluid deliverysystem.
 63. The relay device according to claim 61, wherein thedifferent communication protocols utilize different informationpackaging for communications transmitted from the sensor system throughthe relay device to the fluid delivery system.
 64. A relay device fortransferring information between a sensor system and a fluid deliverysystem, wherein the sensor system measures a physiologicalcharacteristic level of a user, and the fluid delivery system infuses afluid into the user, the device comprising: a sensor system transceiverfor transmitting and receiving one or more communications to and fromthe sensor system, wherein the communications are transmitted andreceived in a sensor system format; a delivery system transceiver fortransmitting and receiving one or more communications to and from thefluid delivery system, wherein the communications are transmitted andreceived in a delivery system format; a processor for processing thecommunications from the sensor system and the fluid delivery system,wherein the processor converts the communications received from thesensor system in the sensor system format for transmission in thedelivery system format to the fluid delivery system, and further whereinthe processor converts the communications received from the fluiddelivery system in the delivery system format for transmission in thesensor system format to the sensor system.
 65. The relay deviceaccording to claim 64, wherein at least one of the communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system include data indicative of thephysiological characteristic level of the user.
 66. The relay deviceaccording to claim 64, wherein at least one of the communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system includes one or more commands forprogramming an amount of the fluid to be infused into the user basedupon data indicative of the physiological characteristic level of theuser obtained by the sensor system.
 67. The relay device according toclaim 64, wherein at least one of the communications transmitted fromthe sensor system to the relay device includes data indicative of thephysiological characteristic level of the user, and at least one of thecommunications transmitted from the relay device and received by thefluid delivery system includes one or more commands for programming anamount of the fluid to be infused into the user based upon the dataindicative of the physiological characteristic level of the user. 68.The relay device according to claim 67, wherein the relay device furtherincludes: a display device coupled to the processor for displaying datato the user; and a user interface coupled to the processor for acceptingone or more inputs from the user, wherein at least one of the inputscauses the display device to display the data indicative of thephysiological characteristic level of the user.
 69. The relay deviceaccording to claim 68, wherein at least another one of the inputsgenerates the one or more commands the for programming amount of thefluid to be infused into the user based upon the data indicative of thephysiological characteristic level of the user.
 70. The relay deviceaccording to claim 64, wherein the sensor system format and the deliverysystem format utilize different frequencies for communicationstransmitted between the sensor system and the fluid delivery systemthrough the relay device.
 71. The relay device according to claim 64,wherein the sensor system format and the delivery system format utilizedifferent communication protocols for communications transmitted betweenthe sensor system and the fluid delivery system through the relaydevice.
 72. The relay device according to claim 71, wherein thedifferent communication protocols utilize different carrier media forcommunications transmitted between the sensor system and the fluiddelivery system through the relay device.
 73. The relay device accordingto claim 71, wherein the different communication protocols utilizedifferent information packaging for communications transmitted betweenthe sensor system and the fluid delivery system through the relaydevice.
 74. An infusion system for infusing a fluid into a user, theinfusion system comprising: a sensor system including: a sensor forproducing a signal indicative of a physiological characteristic level ofthe user; a sensor system processor coupled to the sensor for processingthe signal indicative of the physiological characteristic level of theuser; and a sensor system transmitter coupled to the sensor systemprocessor for transmitting one or more communications in a sensor systemformat; and a fluid delivery system including: a delivery systemhousing; a relay device contained in the delivery system housing, therelay device including: a relay device receiver for receiving thecommunications from the sensor system in the sensor system format; arelay device processor for processing the communications from the sensorsystem and converting the communications for transmission in a deliverysystem format; and a relay device transmitter for transmitting theconverted communications in the delivery system format; a deliverysystem receiver contained in the delivery system housing for receivingthe communications from the relay device in the delivery system format;and a delivery system processor contained in the delivery system housingand coupled to the delivery system receiver for processing thecommunications from the relay device in the delivery system format andcontrolling an amount of the fluid infused into the user; wherein theamount of the fluid infused into the user is determined based upon dataindicative of the physiological characteristic level of the userobtained by the sensor system.
 75. The infusion system according toclaim 74, wherein at least one of the communications transmitted fromthe sensor system through the relay device and received by the fluiddelivery system include data indicative of the physiologicalcharacteristic level of the user.
 76. The infusion system according toclaim 75, wherein the communications including the data indicative ofthe physiological characteristic level of the user are automaticallytransmitted from the sensor system through the relay device and receivedby the fluid delivery system.
 77. The infusion system according to claim76, wherein the fluid delivery system further includes a display devicecontained in the delivery system housing and coupled to the deliverysystem processor for automatically displaying to the user the dataindicative of the physiological characteristic level of the user. 78.The infusion system according to claim 76, wherein the fluid deliverysystem further includes: a display device contained in the deliverysystem housing and coupled to the delivery system processor fordisplaying data to the user; and a user interface contained in thedelivery system housing and coupled to the delivery system processor foraccepting one or more inputs from the user, wherein at least one of theinputs causes the display device to display the data indicative of thephysiological characteristic level of the user received by the fluiddelivery system.
 79. The infusion system according to claim 76, whereinthe fluid delivery system further includes a memory contained in thedelivery system housing for storing the data indicative of thephysiological characteristic level of the user received by the fluiddelivery system.
 80. The infusion system according to claim 79, whereinthe fluid delivery system further includes a display device contained inthe delivery system housing and coupled to the delivery system processorfor displaying to the user a historical trend or graph using the storeddata indicative of the physiological characteristic level of the userreceived by the fluid delivery system.
 81. The infusion system accordingto claim 79, wherein the fluid delivery system further includes: adisplay device contained in the delivery system housing and coupled tothe delivery system processor for displaying data to the user; and auser interface contained in the delivery system housing and coupled tothe delivery system processor for accepting one or more inputs from theuser, wherein at least one of the inputs causes the display device todisplay the most recent data indicative of the physiologicalcharacteristic level of the user received by the fluid delivery system.82. The infusion system according to claim 75, wherein the fluiddelivery system further includes: a display device contained in thedelivery system housing and coupled to the delivery system processor fordisplaying data to the user; and a user interface contained in thedelivery system housing and coupled to the delivery system processor foraccepting one or more inputs from the user, wherein at least one of theinputs causes the display device to display the data indicative of thephysiological characteristic level of the user received by the fluiddelivery system.
 83. The infusion system according to claim 75, whereinthe fluid delivery system further includes a user interface contained inthe delivery system housing and coupled to the delivery system processorfor accepting one or more inputs from the user, wherein at least one ofthe inputs programs the amount of the fluid infused into the user basedupon the data indicative of the physiological characteristic level ofthe user received by the fluid delivery system.
 84. The infusion systemaccording to claim 75, wherein the fluid delivery system furtherincludes: a bolus estimator used in conjunction with the delivery systemprocessor for estimating the amount of the fluid to be infused into theuser based upon the data indicative of the physiological characteristiclevel of the user received by the fluid delivery system; an indicationdevice coupled to the bolus estimator for indicating the estimatedamount of fluid to be infused into the user; and a user interface foraccepting one or more inputs from the user, wherein at least one of theinputs accepts or modifies the estimated amount of the fluid to beinfused into the user.
 85. The infusion system according to claim 75,wherein the fluid delivery system further includes a closed loopalgorithm executed by the delivery system processor for automaticallydetermining the amount of the fluid to be infused into the user basedupon the data indicative of the physiological characteristic level ofthe user received by the fluid delivery system and causing the fluiddelivery system to infuse the determined amount of the fluid into theuser.
 86. The infusion system according to claim 75, wherein the fluiddelivery system further includes an indication device for indicatingwhen the data indicative of the physiological characteristic level ofthe user received by the fluid delivery system is above or below atarget characteristic value.
 87. The infusion system according to claim75, wherein the data indicative of the physiological characteristiclevel of the user received by the fluid delivery system is uncalibrateddata, and the fluid delivery system further includes a calibrationalgorithm executed by the delivery system processor for calibrating theuncalibrated data to generate one or more measurements indicative of thephysiological characteristic level of the user.
 88. The infusion systemaccording to claim 74, wherein the sensor system format and the deliverysystem format utilize different frequencies for communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system.
 89. The infusion system according to claim74, wherein the sensor system format and the delivery system formatutilize different communication protocols for communications transmittedfrom the sensor system through the relay device and received by thefluid delivery system.
 90. The infusion system according to claim 89,wherein the different communication protocols utilize different carriermedia for communications transmitted from the sensor system through therelay device and received by the fluid delivery system.
 91. The infusionsystem according to claim 89, wherein the different communicationprotocols utilize different information packaging for communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system.
 92. The infusion system according to claim74, wherein the communications transmitted from the sensor systemthrough the relay device and received by the fluid delivery system aretransmitted using radio frequency communication.
 93. The infusion systemaccording to claim 74, wherein the communications transmitted from thesensor system through the relay device and received by the fluiddelivery system are transmitted using infrared communication.
 94. Theinfusion system according to claim 74, wherein the delivery systemprocessor has a unique identification code, and the sensor systemprocessor has the capability to learn the unique identification code ofthe delivery system processor, and further wherein the communicationstransmitted from the sensor system through the relay device and receivedby the fluid delivery system include the unique identification code ofthe delivery system processor to substantially avoid interference withother devices.
 95. The infusion system according to claim 74, whereinthe sensor system processor has a unique identification code, and thedelivery system processor has the capability to learn the uniqueidentification code of the sensor system processor, and further whereinthe communications transmitted from the sensor system through the relaydevice and received by the fluid delivery system include the uniqueidentification code of the sensor system processor to substantiallyavoid interference with other devices.
 96. The infusion system accordingto claim 74, wherein the sensor system is a glucose monitoring system,and the fluid delivery system is an insulin infusion device.